Experimental women's cancer drug boosts survival rates in notable study
A new drug is showing promise in tackling treatment-resistant ovarian cancer.
Relacorilant, the drug tested in a phase 3 ROSELLA trial with Corcept Therapeutics in California, was found to improve overall survival and progression of the disease when matched with a chemotherapy drug called nab-paclitaxel.
The ROSELLA trial, conducted in collaboration with The GOG Foundation, analyzed 381 patients around the world, including the U.S., Europe, South Korea, Brazil, Argentina, Canada and Australia, according to a press release.
The large, randomized phase 3 study revealed a 30% reduction in risk of disease progression in patients with platinum-resistant ovarian cancer, compared to those just treated with nab-paclitaxel. (Some types of chemotherapy contain the element platinum.)
The researchers also noted "significant improvement" in overall survival with this combination of drugs.
Relacorilant, which is administered as an oral pill, was reportedly "well-tolerated" by patients without increased side effects.
"A 30% decrease in risk of recurrence and a 31% decreased risk of death is promising."
The drug is administered by mouth one day before, the day of and one day after nab-paclitaxel therapy, which is given via infusion every week.
The findings will be presented at a medical conference later this year, researchers say. Results from the Phase 2 were published in the Journal of Clinical Oncology in 2023.
Ovarian cancer is the fifth most common cause of cancer death in women and is the deadliest of gynecologic cancers, according to the Ovarian Cancer Research Alliance.
Alexander B. Olawaiye, MD, director of gynecological cancer research at Magee-Women's Hospital at the University of Pittsburgh and principal investigator in the ROSELLA trial, discussed the results with Fox News Digital.
Olawaiye echoed that this new agent is the "first of its kind" in the battle against cancers that don't have many treatment options.
"That's what makes the findings of this study really exciting, because it did show a very significant improvement in both progression-free survival and overall survival," he said.
The expert shared his gratitude to his research team, mentioning that they "never stopped trying" for women undergoing treatment.
"I want to congratulate the women that are being treated for ovarian cancer — first, for helping us to do this trial and second, for the potential that we may now have another option on the block."
Dr. Brian Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida, also commented on these findings in an interview with Fox News Digital.
"We know ovarian cancer is very, very difficult to treat, particularly in those patients who have a disease that's resistant to the standard chemotherapies," he said.
"For a long time, we've been trying to find treatments that can help patients not only keep the disease away longer, but also live longer. And most of the trials, unfortunately, have been negative."
Slomovitz, a member of The GOG Foundation, said he considers the ROSELLA trial an "opportunity to use a unique drug" that has shown "positive, encouraging results."
"A 30% decrease in risk of recurrence and a 31% decreased risk of death is promising," he stated.
"To see data like this is refreshing, and it represents something that's exciting for our patients who suffer from ovarian cancer."
Olawaiye shared his hope for the treatment to receive clinical approval "pretty soon."
For more Health articles, visit www.foxnews.com/health
As research and technology advance, various cancer treatments have surfaced in the last several years.
Olawaiye commented that the past two decades have been a "very exciting time," as there's been an "explosion of approvals" for cancer therapies.
"Today's news about Relacorilant is just another addition," he said.
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DESTINY-Endometrial01 Phase 3 Trial of ENHERTU ® Initiated as First-Line Therapy in Patients with HER2 Expressing Primary Advanced or Recurrent Endometrial Cancer
TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--The first patient has been dosed in the DESTINY-Endometrial01 phase 3 trial evaluating ENHERTU ® (trastuzumab deruxtecan) in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer. DESTINY-Endometrial01 will be conducted in collaboration with The GOG Foundation, Inc. (GOG-F) and the European Network of Gynecological Oncological Trial (ENGOT). ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). Endometrial cancer that is recurrent or diagnosed in advanced stages has a median overall survival of up to 30 months. 1 While there have been recent treatment advances, there is still a need to further improve outcomes for patients. HER2 expression (IHC 3+/2+) is associated with aggressive disease and is present in 18% to 56% of endometrial cancers. 2,3,4,5,6 There currently are no HER2 directed medicines approved in the first-line endometrial cancer setting. 'Following the positive results in the endometrial cancer cohort of DESTINY-PanTumor02, which contributed to a tumor agnostic approval for previously treated patients with HER2 positive metastatic tumors in several regions, we are initiating this first phase 3 trial of ENHERTU in the first-line setting of advanced endometrial cancer,' said Mark Rutstein, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo. 'The DESTINY-Endometrial01 trial will help us better understand the role of ENHERTU in combination with immunotherapy as a potential treatment strategy to help improve outcomes compared to the current standard of care in this specific gynecological cancer setting.' About DESTINY-Endometrial01 DESTINY-Endometrial01 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/2+), pMMR, primary advanced (stage III/IV) or first recurrent endometrial cancer of any histologic subtype except sarcoma. Patients will be randomized in a 1:1:1 ratio to receive either ENHERTU in combination with rilvegostomig, ENHERTU in combination with pembrolizumab or platinum-based chemotherapy in combination with pembrolizumab. The primary endpoint is progression-free survival (PFS) as assessed by blinded independent central review (BICR). The key secondary endpoint is overall survival. Additional secondary endpoints include PFS as assessed by investigator, objective response rate, duration of response and safety. DESTINY-Endometrial01 will enroll approximately 600 patients across multiple sites in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit Rilvegostomig is AstraZeneca's PD-1/TIGIT bispecific antibody. The TIGIT component of rilvegostomig is derived from the clinical-stage anti-TIGIT antibody, COM902, developed by Compugen Ltd. (Nasdaq/TASE: CGEN). Pembrolizumab (KEYTRUDA ®) is Merck's (known as MSD outside of the US and Canada) anti-PD-1 therapy. About Endometrial Cancer Endometrial cancer is the second most common gynecologic cancer and the sixth most common cancer among women worldwide. 7 Approximately 420,000 endometrial cancer cases were diagnosed in 2022, with more than 97,000 deaths globally. 8 Incidence and mortality rates of endometrial cancer are expected to increase by approximately 61% and 87% respectively by 2050. 9 Patients with advanced or recurrent endometrial cancer have a poor prognosis, with a median overall survival of up to 30 months. 1 Endometrial cancer comprises several molecular subtypes. 10 Approximately 20% to 30% of all endometrial cancers exhibit high microsatellite instability (MSI) due to a defective mismatch repair system and are classified as MSI-high or MMR deficient (dMMR). 10 The remaining 70% to 80% of cases are considered mismatch repair proficient (pMMR) tumors. 10 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors. 11 HER2 expression (IHC 3+/ 2+) is present in 18% to 56% of endometrial cancers and is associated with markers of aggressive disease. 2,3,4,5,6 HER2 expression is observed almost exclusively in pMMR tumors. 2 Standard of care first-line treatment of advanced or recurrent endometrial cancer has long included carboplatin plus paclitaxel. 12 The treatment paradigm has recently evolved to incorporate an immune checkpoint inhibitor with carboplatin and paclitaxel, particularly for patients with dMMR endometrial cancer; however, the benefit of this treatment regimen in pMMR endometrial cancer is less pronounced. 13,14,15,16 There currently are no HER2 directed medicines approved in the first-line endometrial cancer setting. About ENHERTU ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca's ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4 mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. ENHERTU (5.4 mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. ENHERTU (5.4 mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that has progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. ENHERTU (5.4 mg/kg) is approved in more than 60 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (6.4 mg/kg) is approved in more than 70 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (5.4 mg/kg) is approved in Brazil, Israel, Russia, Saudi Arabia, Switzerland, Taiwan, U.K. and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the ENHERTU Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other anti-cancer therapies across multiple HER2 targetable cancers. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY ® in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo's DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. ENHERTU U.S. Important Safety Information Indications ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either: In the metastatic setting, or In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy Unresectable or metastatic: Hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy Unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen Unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. W ARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms. Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception. Expand Contraindications None. Warnings and Precautions Interstitial Lung Disease / Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose 1 level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) In patients with metastatic breast cancer, HER2-mutant NSCLC, and other solid tumors treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.9% of patients treated with ENHERTU. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21). Neutropenia Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 10 9 /L), interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 10 9 /L), interrupt ENHERTU until resolved to Grade 2 or less, then reduce dose by 1 level. For febrile neutropenia (ANC <1.0 x 10 9 /L and temperature >38.3° C or a sustained temperature of ≥38° C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by 1 level. HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) In patients with metastatic breast cancer, HER2-mutant NSCLC, and other solid tumors treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 65% of patients. Nineteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 939). Febrile neutropenia was reported in 1.2% of patients. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients. Left Ventricular Dysfunction Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is 20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of 20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment. HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) In patients with metastatic breast cancer, HER2-mutant NSCLC, and other solid tumors treated with ENHERTU 5.4 mg/kg, LVEF decrease was reported in 4.6% of patients, of which 0.6% were Grade 3 or 4. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF. Embryo-Fetal Toxicity ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose of ENHERTU. Additional Dose Modifications Thrombocytopenia For Grade 3 thrombocytopenia (platelets <50 to 25 x 10 9 /L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 10 9 /L) interrupt ENHERTU until resolved to Grade 1 or less, then reduce dose by 1 level. Adverse Reactions HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg intravenously every 3 weeks in 2233 patients in Study DS8201-A-J101 (NCT02564900), DESTINY-Breast01, DESTINY-Breast02, DESTINYBreast03, DESTINY-Breast04, DESTINY-Breast06, DESTINY-Lung01, DESTINY-Lung02, DESTINY-CRC02, and DESTINY-PanTumor02. Among these patients, 67% were exposed for >6 months and 38% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (73%), nausea (72%), decreased hemoglobin (67%), decreased neutrophil count (65%), decreased lymphocyte count (60%), fatigue (55%), decreased platelet count (48%), increased aspartate aminotransferase (46%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (39%), vomiting (38%), alopecia (37%), constipation (32%), decreased blood potassium (32%), decreased appetite (31%), diarrhea (30%), and musculoskeletal pain (24%). HER2-Positive Metastatic Breast Cancer DESTINY-Breast03 The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least 1 dose of ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30) for patients who received ENHERTU. Serious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were vomiting, ILD, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (1 patient each). ENHERTU was permanently discontinued in 14% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD/pneumonitis. Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, neutropenia, and fatigue. The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (74%), decreased neutrophil count (70%), increased aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte count (55%), increased alanine aminotransferase (53%), decreased platelet count (52%), fatigue (49%), vomiting (49%), increased blood alkaline phosphatase (49%), alopecia (37%), decreased blood potassium (35%), constipation (34%), musculoskeletal pain (31%), diarrhea (29%), decreased appetite (29%), headache (22%), respiratory infection (22%), abdominal pain (21%), increased blood bilirubin (20%), and stomatitis (20%). HER2-Low and HER2-Ultralow Metastatic Breast Cancer DESTINY-Breast06 The safety of ENHERTU was evaluated in 434 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast06. The median duration of treatment was 11 months (range: 0.4 to 39.6) for patients who received ENHERTU. Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, COVID-19, febrile neutropenia, and hypokalemia. Fatalities due to adverse reactions occurred in 2.8% of patients including ILD (0.7%); sepsis (0.5%); and COVID-19 pneumonia, bacterial meningoencephalitis, neutropenic sepsis, peritonitis, cerebrovascular accident, general physical health deterioration (0.2% each). ENHERTU was permanently discontinued in 14% of patients. The most frequent adverse reaction (>2%) associated with permanent discontinuation was ILD/pneumonitis. Dose interruptions due to adverse reactions occurred in 48% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were COVID-19, decreased neutrophil count, anemia, pyrexia, pneumonia, decreased white blood cell count, and ILD. Dose reductions occurred in 25% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, fatigue, decreased platelet count, and decreased neutrophil count. The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased neutrophil count (75%), nausea (70%), decreased hemoglobin (69%), decreased lymphocyte count (66%), fatigue (53%), decreased platelet count (48%), alopecia (48%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (43%), increased aspartate aminotransferase (41%), decreased blood potassium (35%), diarrhea (34%), vomiting (34%), constipation (32%), decreased appetite (26%), COVID-19 (26%), and musculoskeletal pain (24%). DESTINY-Breast04 The safety of ENHERTU was evaluated in 371 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast04. The median duration of treatment was 8 months (range: 0.2 to 33) for patients who received ENHERTU. Serious adverse reactions occurred in 28% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, pneumonia, dyspnea, musculoskeletal pain, sepsis, anemia, febrile neutropenia, hypercalcemia, nausea, pyrexia, and vomiting. Fatalities due to adverse reactions occurred in 4% of patients including ILD/pneumonitis (3 patients); sepsis (2 patients); and ischemic colitis, disseminated intravascular coagulation, dyspnea, febrile neutropenia, general physical health deterioration, pleural effusion, and respiratory failure (1 patient each). ENHERTU was permanently discontinued in 16% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 39% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, fatigue, anemia, leukopenia, COVID-19, ILD/pneumonitis, increased transaminases, and hyperbilirubinemia. Dose reductions occurred in 23% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, thrombocytopenia, and neutropenia. The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (70%), decreased hemoglobin (64%), decreased neutrophil count (64%), decreased lymphocyte count (55%), fatigue (54%), decreased platelet count (44%), alopecia (40%), vomiting (40%), increased aspartate aminotransferase (38%), increased alanine aminotransferase (36%), constipation (34%), increased blood alkaline phosphatase (34%), decreased appetite (32%), musculoskeletal pain (32%), diarrhea (27%), and decreased blood potassium (25%). HER2-Mutant Unresectable or Metastatic NSCLC (5.4 mg/kg) DESTINY-Lung02 evaluated 2 dose levels (5.4 mg/kg [n=101] and 6.4 mg/kg [n=50]); however, only the results for the recommended dose of 5.4 mg/kg intravenously every 3 weeks are described below due to increased toxicity observed with the higher dose in patients with NSCLC, including ILD/pneumonitis. The safety of ENHERTU was evaluated in 101 patients with HER2-mutant unresectable or metastatic NSCLC who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks until disease progression or unacceptable toxicity in DESTINY-Lung02. Nineteen percent of patients were exposed for >6 months. Serious adverse reactions occurred in 30% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, thrombocytopenia, dyspnea, nausea, pleural effusion, and increased troponin I. Fatality occurred in 1 patient with suspected ILD/pneumonitis (1%). ENHERTU was permanently discontinued in 8% of patients. Adverse reactions which resulted in permanent discontinuation of ENHERTU were ILD/pneumonitis, diarrhea, decreased blood potassium, hypomagnesemia, myocarditis, and vomiting. Dose interruptions of ENHERTU due to adverse reactions occurred in 23% of patients. Adverse reactions which required dose interruption (>2%) included neutropenia and ILD/pneumonitis. Dose reductions due to an adverse reaction occurred in 11% of patients. The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (61%), decreased white blood cell count (60%), decreased hemoglobin (58%), decreased neutrophil count (52%), decreased lymphocyte count (43%), decreased platelet count (40%), decreased albumin (39%), increased aspartate aminotransferase (35%), increased alanine aminotransferase (34%), fatigue (32%), constipation (31%), decreased appetite (30%), vomiting (26%), increased alkaline phosphatase (22%), and alopecia (21%). HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01. Patients intravenously received at least 1 dose of either ENHERTU (N=125) 6.4 mg/kg every 3 weeks or either irinotecan (N=55) 150 mg/m 2 biweekly or paclitaxel (N=7) 80 mg/m 2 weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) for patients who received ENHERTU. Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in 1 patient each (0.8%). ENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and decreased blood potassium. Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia. The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (75%), decreased white blood cell count (74%), decreased neutrophil count (72%), decreased lymphocyte count (70%), decreased platelet count (68%), nausea (63%), decreased appetite (60%), increased aspartate aminotransferase (58%), fatigue (55%), increased blood alkaline phosphatase (54%), increased alanine aminotransferase (47%), diarrhea (32%), decreased blood potassium (30%), vomiting (26%), constipation (24%), increased blood bilirubin (24%), pyrexia (24%), and alopecia (22%). HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors The safety of ENHERTU was evaluated in 347 adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast01, DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. The median duration of treatment was 8.3 months (range 0.7 to 30.2). Serious adverse reactions occurred in 34% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were sepsis, pneumonia, vomiting, urinary tract infection, abdominal pain, nausea, pneumonitis, pleural effusion, hemorrhage, COVID-19, fatigue, acute kidney injury, anemia, cellulitis, and dyspnea. Fatalities due to adverse reactions occurred in 6.3% of patients including ILD/pneumonitis (2.3%), cardiac arrest (0.6%), COVID-19 (0.6%), and sepsis (0.6%). The following events occurred in 1 patient each (0.3%): acute kidney injury, cerebrovascular accident, general physical health deterioration, pneumonia, and hemorrhagic shock. ENHERTU was permanently discontinued in 15% of patients, of which ILD/pneumonitis accounted for 10%. Dose interruptions due to adverse reactions occurred in 48% of patients. The most frequent adverse reactions (>2%) associated with dose interruption were decreased neutrophil count, anemia, COVID-19, fatigue, decreased white blood cell count, and ILD/pneumonitis. Dose reductions occurred in 27% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, decreased neutrophil count, ILD/pneumonitis, and diarrhea. The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (75%), nausea (69%), decreased hemoglobin (67%), decreased neutrophil count (66%), fatigue (59%), decreased lymphocyte count (58%), decreased platelet count (51%), increased aspartate aminotransferase (45%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (36%), vomiting (35%), decreased appetite (34%), alopecia (34%), diarrhea (31%), decreased blood potassium (29%), constipation (28%), decreased sodium (22%), stomatitis (20%), and upper respiratory tract infection (20%). Use in Specific Populations Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months after the last dose of ENHERTU. Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose. Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for 7 months after the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose. Infertility: ENHERTU may impair male reproductive function and fertility. Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients. Geriatric Use: Of the 1741 patients with HER2-positive, HER2-low, or HER2-ultralow breast cancer treated with ENHERTU 5.4 mg/kg, 24% were ≥65 years and 4.9% were ≥75 years. No overall differences in efficacy within clinical studies were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (61%) as compared to younger patients (52%). Of the 101 patients with HER2-mutant unresectable or metastatic NSCLC treated with ENHERTU 5.4 mg/kg, 40% were ≥65 years and 8% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. Of the 125 patients with HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg in DESTINY-Gastric01, 56% were ≥65 years and 14% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. Of the 192 patients with HER2-positive (IHC 3+) unresectable or metastatic solid tumors treated with ENHERTU 5.4 mg/kg in DESTINY-PanTumor02, DESTINY-Lung01, or DESTINY-CRC02, 39% were ≥65 years and 9% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. Renal Impairment: A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Monitor patients with moderate renal impairment more frequently. The recommended dosage of ENHERTU has not been established for patients with severe renal impairment (CLcr <30 mL/min). Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor, DXd. The recommended dosage of ENHERTU has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST). To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit ____________________ References 1 Coleman RL, et al. JHEOR. 2023;10(2):82-90. 2 Vermij L, et al. Cancers (Basel). 2020;13(1):44. 3 Buza N. Arch Pathol Lab Med. 2021;145(6):687–691. 4 Uzunparmaek B, et al. Ann Oncol. 2023;34(11):1035-1046. 5 Semiz SH, et al. Turkish Journal of Pathology. 2023;39(1):055-063 6 Halle MK, et al. Br J Cancer. 2017;118(3):378-387. 7 GLOBOCAN. International agency for research on cancer (IARC): Age-Standardized Rate (World) per 100 000, Incidence and Mortality, Females, all ages in 2022. Accessed June 2025. 8 GLOBOCAN. Uterine Cancer Fact Sheet. Accessed June 2025. 9 World Health Organization. Cancer Tomorrow: Corpus Uteri. Accessed June 2025. 10 Corr B, et al. BMJ Med. 2022;1:e000152. 11 Omar N, et al. Pathogenesis. 2015 2(3):1-9. 12 Miller DS, et al. J Clin Oncol. 2020;38:3841–3850. 13 Mirza MR, et al. N Engl J Med. 2023:8;388:2145–2158. 14 Eskander RN, et al. N Engl J Med. 2023;388:2159–2170. 15 Westin SN, et al. J Clin Oncol. 2024;42:283–299. 16 Colombo N, et al. Lancet Oncol. 2024;25:1135–1146. Expand
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Do you need a magnesium supplement? Experts share symptoms of deficiency
Magnesium is said to be a natural remedy for a variety of ailments — but is it really necessary to supplement, and if so, how much do you need? Fox News Digital spoke to multiple health experts about the multipurpose mineral, which plays a role in over 300 of the body's enzyme systems and helps with energy production, muscle and nerve function, and blood pressure regulation. Magnesium may help lower the risk of certain diseases and could help to improve sleep, reduce stress and anxiety, and prevent nighttime muscle cramps, sources said. Common Supplements And Medications Could Cause Liver Damage, Studies Show The nutrient "supports a stable heartbeat and prevents arrhythmias, works with calcium and vitamin D to keep bones strong, and aids insulin sensitivity and glucose metabolism," Dr. Heather Viola, a primary care physician with Mount Sinai Health System in New York City, told Fox News Digital. Magnesium can also help with constipation relief, migraine prevention and PMS symptoms, according to Eleana Quattrocchi, a pharmacist and associate professor of pharmacy practice at Long Island University in Brooklyn, New York. Read On The Fox News App Many Americans do not get enough magnesium in their diet, according to the National Institutes of Health (NIH) Office of Dietary Supplements. "Habitually low intakes of magnesium induce changes in biochemical pathways that can increase the risk of illness over time," the NIH website states. Studies have shown that up to 15% of people in the U.S. could experience magnesium deficiency. Common Daily Vitamin Could Slow Biological Aging, Major Study Suggests Lack of magnesium can raise the risk of hypertension, cardiovascular disease, type 2 diabetes, migraine headaches and osteoporosis. Potential symptoms include insomnia, muscle cramps, constipation, nausea and vomiting, fatigue, weakness, numbness, tingling, personality changes and heart arrhythmias, experts say. In severe cases, hypocalcemia (low calcium levels) or hypokalemia (low potassium levels) might occur, according to the NIH Office of Dietary Supplements. Blood tests can help detect low levels, but Viola cautioned that those tests "aren't perfect" because most magnesium is inside cells, not in serum. Certain medical conditions, alcoholism, some medications and a diet lacking in the mineral may contribute to magnesium deficiency. "People with gastrointestinal disease, such as Celiac disease or Crohn's disease, or those who have had a gastric bypass may develop magnesium deficiency," Sue-Ellen Anderson-Haynes, a spokesperson for the Academy of Nutrition and Dietetics and a registered dietitian who owns 360Girls&Women in Massachusetts, told Fox News Digital. The recommended daily dietary intake of magnesium is 310 to 320 mg per day for adult women and 400 to 420 mg per day for adult men. "The majority of magnesium is found in plants liked nuts, seeds and beans," Anderson-Haynes told Fox News Digital. "For reference, 1 ounce (2 tablespoons) of pumpkin seeds provides 156 mg of magnesium and 1 ounce of chia seeds is 111 mg (26% DV) of magnesium."Common Household Spice May Interfere With Medicines, Study Suggests Some specific sources of magnesium include peanut butter, bananas, avocado, nuts (almonds), black beans, leafy greens (like spinach and kale), whole grains, yogurt and dark chocolate. While dietary sources are the best way to meet daily magnesium requirements, supplements are recommended in certain cases, health experts told Fox News Digital. "A supplement should be taken when a known deficiency or a health condition is present with excessive magnesium losses, like alcoholism," Samantha Dieras, a registered dietitian and director of ambulatory nutrition services at the Mount Sinai Hospital in New York City, told Fox News Digital. Physicians may recommend supplements for magnesium-deficient patients or for individuals who are taking certain medications, such as diuretics or Proton pump inhibitors that can deplete magnesium, Viola noted. For more Health articles, visit It is possible to ingest too much supplementation. "You can get too much magnesium, but mainly from supplements, not food," Viola said. "It's very safe from food, as kidneys eliminate the excess." Over-supplementing can cause diarrhea, nausea and lethargy, according to the expert. Magnesium supplements come in different forms for various purposes, which are absorbed in different ways. Click Here To Sign Up For Our Health Newsletter One of the most popular forms is magnesium citrate, which is typically taken orally to raise levels in the body and alleviate constipation, according to Healthline. Magnesium chloride is another good choice for correcting deficiencies, and also alleviates heartburn and constipation. For those who can't tolerate other forms, magnesium lactate and magnesium malate may be gentler on the digestive system, Healthline noted. Magnesium taurate is known to have potential benefits for regulating high blood sugar and high blood pressure, while magnesium L-threonate could potentially help support brain health. "The magnesium salts used for a calming effect are glycinate and taurate," Quattrocchi told Fox News Digital. Magnesium glycinate has also been shown to improve sleep, reduce mental health issues and treat inflammatory conditions, according to Healthline. Click Here To Get The Fox News Ap Individuals should speak with their physician before starting magnesium supplements, as it may interfere with some medications and medical article source: Do you need a magnesium supplement? Experts share symptoms of deficiency
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Psychedelics as potential mental health treatment are explored by Trump administration
The Trump administration has expressed interest in exploring psychedelics for their potential in treating PTSD and other debilitating mental health issues, various officials have shared. "The Department shares the goal of ensuring that all Americans — especially our nation's veterans — have access to safe and effective treatments for conditions such as PTSD, addiction and depression," a spokesperson for the U.S. Department of Health and Human Services (HHS), run by Sec. Robert J. Kennedy Jr., said in a statement provided to Fox News Digital. "Secretary Kennedy is committed to applying rigorous, evidence-based science to research efforts aimed at addressing these serious health challenges." Fda Approves First Ai Tool To Predict Breast Cancer Risk In recent years, researchers have been actively investigating the potential of psychedelics, such as MDMA and psilocybin ("magic mushrooms") to treat mental health disorders. MDMA is not approved for clinical use by the U.S. Food and Drug Administration (FDA), but can be studied in clinical settings. Read On The Fox News App Psilocybin is listed as a Schedule I substance under the Controlled Substances Act, which means it has "a high potential for abuse, [is not] currently accepted for medical use in treatment in the United States, and [has] a lack of accepted safety for use under medical supervision." Psilocybin-assisted therapy, however, is legal in Oregon, Colorado and New Mexico. Psychedelic medicines are "showing real promise," according to Dr. Luke Twelves, general practitioner and vice president of medical for Lindus Health in London. Clinical trials have found such treatments safe and effective for patients battling serious mental health issues, according to Twelves. Common Supplements And Medications Could Cause Liver Damage, Studies Show "Take psilocybin, for example — it's demonstrating remarkable results for severe depression that hasn't responded to other medications," he told Fox News Digital. "MDMA is showing similar breakthroughs for PTSD treatment." Clinical trials are also investigating how psychedelics could help with end-of-life anxiety, addiction, eating disorders, chronic pain and OCD, he added. Researchers have faced challenges in terms of regulatory hurdles and proper placebo controls, Twelves said. "Given that these treatments could transform [the] lives of people suffering from conditions where nothing else has worked effectively, it's crucial that we complete this research properly," he said. "The goal is to bring safe, proven psychedelic therapies to the patients who need them most." At President Trump's May 1 cabinet meeting, Department of Veterans Affairs Secretary Doug Collins said that "we're opening up the possibility of psychedelic treatment." Retired Army Sergeant Jonathan Lubecki recently told Fox News' Alexandria Hoff that MDMA stopped his PTSD while he was participating in a clinical trial. "[I] took my first dose of MDMA. I've only taken it three times as part of the clinical trial, haven't taken it since, and haven't found the need to take it since, because I haven't had PTSD," he said. Peter Kasperowicz, Department of Veterans Affairs press secretary, told Fox News Digital the department is safely exploring all avenues that promote the health of veterans. Fallujah Vet Turns Medal Of Heroism Into A Healing Mission For Fellow Warriors With Service Dogs Program "Preliminary findings have produced positive results on psychedelic-assisted therapies for treating mental health conditions," he said. The VA is currently running 11 clinical trials in various phases, with a total of some 800 veterans expected to participate. "The goal of these trials is to determine whether compounds such as MDMA and psilocybin can treat veterans with post-traumatic stress disorder, treatment-resistant depressive disorder, major depressive disorder and potentially other mental health conditions," said Kasperowicz. An MDMA study published in the Jan. 2025 issue of The American Journal of Psychiatry found that the substance is "unlike classical psychedelics." The study noted, "MDMA allows the individual to maintain intact ego functioning and a greater degree of cognitive and perceptual lucidity while still experiencing a prosocial altered state of consciousness that facilitates deeply emotional therapeutic breakthroughs." Click Here To Sign Up For Our Health Newsletter The researchers concluded that MDMA showed "enhanced levels of trust, empathy, self-compassion and a 'window of tolerance'" that traditional psychotherapy lacks. Doug Drysdale, CEO of the Canadian pharmaceutical company Cybin, told Fox News Digital that "the time is now to address the mental health crisis." He said it is "gratifying" that administration officials value the potential benefits of looking into alternative mental health treatments. Cybin is currently in phase 3 of a study of CYB003, a type of psilocybin that has been granted breakthrough therapy designation by the FDA as an additional treatment for major depressive disorder (MDD). "In Cybin's completed Phase 2 MDD study, long-term efficacy results showed that 71% of participants were in remission from depression, and 100% of participants responded to treatment at 12 months after just two 16 mg doses of CYB003," said Drysdale. Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and Fox News' senior medical analyst, previously interviewed two of the country's top researchers on psychedelics — Dr. Rachel Yehuda, founder and director of the Center for Psychedelic Psychotherapy and Trauma Research at Mt. Sinai in New York, and Dr. Charles Marmar, director of the PTSD research program at NYU Langone. "They agree there is therapeutic potential if very carefully studied under very strict medical guidance, but there is a huge downside in terms of unregulated recreational uses," Siegel told Fox News Digital at the time. "Both doctors see likely therapeutic value to psychedelics if carefully managed by medical experts," Siegel added. Ryan Moss, chief science officer at Filament Health, a clinical-stage natural psychedelic drug development company in Canada, emphasized it's important to administer psychedelics in a safe setting when treating mental health conditions. For more Health articles, visit "Psychedelic experiences can sometimes feature anxiety, hallucinations and paranoia," Moss previously told Fox News Digital. "Some patients using traditional psychedelics have reported experiencing adverse cardiovascular events during clinical trials." To mitigate these risks, Moss recommended clinical trial participants receive thorough preparation and monitoring by trained professionals during sessions. Melissa Rudy and Angelica Stabile, both of Fox News Digital, contributed article source: Psychedelics as potential mental health treatment are explored by Trump administration
