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Hospital gun-violence prevention programs may be caught in federal funding crossfire

Hospital gun-violence prevention programs may be caught in federal funding crossfire

CBS News10-03-2025
Seven years ago, Erica Green learned through a Facebook post that her brother had been shot.
She rushed to check on him at a hospital run by Denver Health, the city's safety-net system, but she was unable to get information from emergency room workers, who complained that she was creating a disturbance.
"I was distraught and outside, crying, and Jerry came out of the front doors," she said.
Jerry Morgan is a familiar face from Green's Denver neighborhood. He had rushed to the hospital after his pager alerted him to the shooting. As a violence prevention professional with the At-Risk Intervention and Mentoring program, or AIM, Morgan supports gun-violence patients and their families at the hospital — as he did the day Green's brother was shot.
"It made the situation of that traumatic experience so much better. After that, I was, like, I want to do this work," Green said.
Today, Green works with Morgan as the program manager for AIM, a hospital-linked violence intervention program launched in 2010 as a partnership between Denver Health and the nonprofit Denver Youth Program. It since has expanded to include Children's Hospital Colorado and the University of Colorado Hospital.
AIM is one of dozens of hospital-linked violence intervention programs around the country. The programs aim to uncover the social and economic factors that contributed to someone ending up in the ER with a bullet wound: inadequate housing, job loss, or feeling unsafe in one's neighborhood, for example.
Such programs that take a public health approach to stopping gun violence have had success — one in San Francisco reported a fourfold reduction in violent injury recidivism rates over six years. But President Trump's executive orders calling for the review of the Biden administration's gun policies and trillions of dollars in federal grants and loans have created uncertainty around the programs' long-term federal funding. Some organizers believe their programs will be just fine, but others are looking to shore up alternative funding sources.
"We've been worried about, if a domino does fall, how is it going to impact us? There's a lot of unknowns," said John Torres, associate director for Youth Alive, an Oakland, California-based nonprofit.
Federal data shows that gun violence became a leading cause of death among children and young adults at the start of this decade and was tied to more than 48,000 deaths among people of all ages in 2022. New York-based pediatric trauma surgeon Chethan Sathya, a National Institutes of Health-funded firearms injury prevention researcher, believes those statistics show that gun violence can't be ignored as a health care issue. "It's killing so many people," Sathya said.
Research shows that a violent injury puts someone at heightened risk for future ones, and the risk of death goes up significantly by the third violent injury, according to a 2006 study published in The Journal of Trauma: Injury, Infection and Critical Care.
Benjamin Li, an emergency medicine physician at Denver Health and the health system's AIM medical director, said the ER is an ideal setting to intervene in gun violence by working to reverse-engineer what led to a patient's injuries.
"If you are just seeing the person, patching them up, and then sending them right back into the exact same circumstances, we know it's going to lead to them being hurt again," Li said. "It's critical we address the social determinants of health and then try to change the equation."
That might mean providing alternative solutions to gunshot victims who might otherwise seek retaliation, said Paris Davis, the intervention programs director for Youth Alive.
"If that's helping them relocate out of the area, if that's allowing them to gain housing, if that's shifting that energy into education or job or, you know, family therapy, whatever the needs are for that particular case and individual, that is what we provide," Davis said.
AIM outreach workers meet gunshot wound victims at their hospital bedsides to have what Morgan, AIM's lead outreach worker, calls a tough, nonjudgmental conversation on how the patients ended up there.
AIM uses that information to help patients access the resources they need to navigate their biggest challenges after they're discharged, Morgan said. Those challenges can include returning to school or work, or finding housing. AIM outreach workers might also attend court proceedings and assist with transportation to health care appointments.
"We try to help in whatever capacity we can, but it's interdependent on whatever the client needs," Morgan said.
Since 2010, AIM has grown from three full-time outreach workers to nine, and this year opened the REACH Clinic in Denver's Five Points neighborhood. The community-based clinic provides wound-care kits; physical therapy; and behavioral, mental and occupational health care. In the coming months, it plans to add bullet removal to its services. It's part of a growing movement of community-based clinics focused on violent injuries, including the Bullet Related Injury Clinic in St. Louis.
Ginny McCarthy, an assistant professor in the Department of Surgery at the University of Colorado, described REACH as an extension of the hospital-based work, providing holistic treatment in a single location and building trust between health care providers and communities of color that have historically experienced racial biases in medical care.
Caught in the Crossfire, created in 1994 and run by Youth Alive in Oakland, is cited as the nation's first hospital-linked violence intervention program and has since inspired others. The Health Alliance for Violence Intervention, a national network initiated by Youth ALIVE to advance public health solutions to gun violence, counted 74 hospital-linked violence intervention programs among its membership as of January.
The alliance's executive director, Fatimah Loren Dreier, compared medicine's role in addressing gun violence to that of preventing an infectious disease, like cholera. "That disease spreads if you don't have good sanitation in places where people aggregate," she said.
Dreier, who also serves as executive director of the Kaiser Permanente Center for Gun Violence Research and Education, said medicine identifies and tracks patterns that lead to the spread of a disease or, in this case, the spread of violence.
"That is what health care can do really well to shift society. When we deploy this, we get better outcomes for everybody," Dreier said.
The alliance, of which AIM is a member, offers technical assistance and training for hospital-linked violence intervention programs and successfully petitioned to make their services eligible for traditional insurance reimbursement.
In 2021, President Joe Biden issued an executive action that opened the door for states to use Medicaid for violence prevention. Several states, including California, New York, and Colorado, have passed legislation establishing a Medicaid benefit for hospital-linked violence intervention programs.
Last summer, then-U.S. Surgeon General Vivek Murthy declared gun violence a public health crisis, and the 2022 Bipartisan Safer Communities Act earmarked $1.4 billion in funding for a wide array of violence-prevention programs through next year.
But in early February, Mr. Trump issued an executive order instructing the U.S. attorney general to conduct a 30-day review of a number of Biden's policies on gun violence. The White House Office of Gun Violence Prevention now appears to be defunct, and recent moves to freeze federal grants created uncertainty among the gun-violence prevention programs that receive federal funding.
AIM receives 30% of its funding from its operating agreement with Denver's Office of Community Violence Solutions, according to Li. The rest is from grants, including Victims of Crime Act funding, through the Department of Justice. As of mid-February, Mr. Trump's executive orders had not affected AIM's current funding.
Some who work with the hospital-linked violence prevention programs in Colorado are hoping a new voter-approved firearms and ammunition excise tax in the state, expected to generate about $39 million annually and support victim services, could be a new source of funding. But the tax's revenues aren't expected to fully flow until 2026, and it's not clear how that money will be allocated.
Trauma surgeon and public health researcher Catherine Velopulos, who is the AIM medical director at the University of Colorado hospital in Aurora, said any interruption in federal funding, even for a few months, would be "very difficult for us." But Velopulos said she was reassured by the bipartisan support for the kind of work AIM does.
"People want to oversimplify the problem and just say, 'If we get rid of guns, it's all going to stop,' or 'It doesn't matter what we do, because they're going to get guns, anyway,'" she said. "What we really have to address is why people feel so scared that they have to arm themselves."
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
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PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery
PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery

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PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery

PADCEV plus KEYTRUDA is the first and only regimen to improve survival when used before and after standard of care (surgical cystectomy) in cisplatin-ineligible patients with muscle-invasive bladder cancer Results will be discussed with global health authorities for potential regulatory filings NEW YORK & TOKYO, August 12, 2025--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive topline results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905). The EV-303 study is evaluating PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor, as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. At the first interim efficacy analysis, the trial demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS), the study's primary endpoint, and overall survival (OS), a key secondary endpoint, with neoadjuvant and adjuvant PADCEV plus KEYTRUDA versus surgery alone. An additional secondary endpoint of pathologic complete response (pCR) rate was also met. Christof Vulsteke, M.D., Ph.D., Head of Integrated Cancer Center Ghent (IKG, Belgium) and Clinical Trial Unit Oncology Ghent and EV-303 principal investigator"Patients with muscle-invasive bladder cancer who are ineligible for cisplatin treatment have not seen a significant treatment advance in decades and face high rates of disease recurrence and a poor prognosis, even after having their bladder removed. These EV-303 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population, demonstrating the potential of this combination to address a critical unmet patient need." The trial is continuing to evaluate the secondary EFS, OS and pCR rate endpoints for neoadjuvant and adjuvant KEYTRUDA versus surgery alone as they continue to mature. The safety profiles for PADCEV plus KEYTRUDA and KEYTRUDA monotherapy were consistent with the known profiles of each treatment regimen. Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas"These results from EV-303 represent a breakthrough for cisplatin-ineligible patients with muscle-invasive bladder cancer, demonstrating the potential of PADCEV in combination with KEYTRUDA when used before and after surgery as a new standard of care. We look forward to presenting further details on these data at an upcoming medical congress." Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally.i MIBC represents approximately 30% of all bladder cancer The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer"PADCEV plus KEYTRUDA has already changed the treatment paradigm for patients with locally advanced or metastatic urothelial cancer as standard of care. These latest results underscore the practice-changing potential of this combination in earlier stages of bladder cancer, where it has the potential to improve outcomes for even more patients. Thank you to the patients and investigators who participated in this trial." Results will be submitted for presentation at an upcoming medical congress and will be discussed with global health authorities for potential regulatory filings. Neoadjuvant and adjuvant PADCEV plus KEYTRUDA is also being evaluated in cisplatin-eligible patients with MIBC in the EV-304 Phase 3 clinical trial (also known as KEYNOTE-B15). About the EV-303 TrialThe EV-303 trial is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA or neoadjuvant and adjuvant KEYTRUDA versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant KEYTRUDA (arm A), surgery alone (arm B) or neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA (arm C).iv The primary endpoint of this trial is EFS between arm C versus arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause. Key secondary endpoints include OS and pCR rate between arm C and arm B, as well as EFS, OS and pCR rate between arm A and arm For more information on the global EV-303 trial, go to About PADCEV™ (enfortumab vedotin)PADCEV™ (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.v Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).vi PADCEV plus KEYTRUDA is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, the European Union, Japan and a number of other countries around the world. PADCEV is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of PADCEV® (enfortumab vedotin-ejfv) U.S. Indication & Important Safety Information BOXED WARNING: SERIOUS SKIN REACTIONS PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. Closely monitor patients for skin reactions. Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. IndicationPADCEV®, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).PADCEV, as a single agent, is indicated for the treatment of adult patients with locally advanced or mUC who: have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. PADCEV Important Safety Information Warnings and Precautions Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 70% (all grades) of the 564 patients treated with PADCEV in combination with pembrolizumab in clinical trials. When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate compared to PADCEV as a single agent. The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash. Grade 3-4 skin reactions occurred in 17% of patients (Grade 3: 16%, Grade 4: 1%), including maculo-papular rash, bullous dermatitis, dermatitis, exfoliative dermatitis, pemphigoid, rash, erythematous rash, macular rash, and papular rash. A fatal reaction of bullous dermatitis occurred in one patient (0.2%). The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Skin reactions led to discontinuation of PADCEV in 6% of patients. Skin reactions occurred in 58% (all grades) of the 720 patients treated with PADCEV as a single agent in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 34% had pruritus. Grade 3-4 skin reactions occurred in 14% of patients, including maculo-papular rash, erythematous rash, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. The median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 8 months). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=75), 24% of patients restarting at the same dose and 24% of patients restarting at a reduced dose experienced recurrent severe skin reactions. Skin reactions led to discontinuation of PADCEV in 3.1% of patients. Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. For persistent or recurrent Grade 2 skin reactions, consider withholding PADCEV until Grade ≤1. Withhold PADCEV and refer for specialized care for suspected SJS, TEN or for Grade 3 skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre-existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials of PADCEV as a single agent, 17% of the 720 patients treated with PADCEV developed hyperglycemia of any grade; 7% of patients developed Grade 3-4 hyperglycemia (Grade 3: 6.5%, Grade 4: 0.6%). Fatal events of hyperglycemia and DKA occurred in one patient each (0.1%). The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. The median time to onset of hyperglycemia was 0.5 months (range: 0 to 20 months). Hyperglycemia led to discontinuation of PADCEV in 0.7% of patients. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. Of the patients who initiated insulin therapy for treatment of hyperglycemia, 66% (23/35) discontinued insulin at the time of last evaluation. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV. Pneumonitis/Interstitial Lung Disease (ILD) Severe, life-threatening or fatal pneumonitis/ILD occurred in patients treated with PADCEV. When PADCEV was given in combination with pembrolizumab, 10% of the 564 patients treated with combination therapy had pneumonitis/ILD of any grade and 4% had Grade 3-4. A fatal event of pneumonitis/ILD occurred in two patients (0.4%). The incidence of pneumonitis/ILD, including severe events, occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of any grade pneumonitis/ILD was 4 months (range: 0.3 to 26 months). In clinical trials of PADCEV as a single agent, 3% of the 720 patients treated with PADCEV had pneumonitis/ILD of any grade and 0.8% had Grade 3-4. The median time to onset of any grade pneumonitis/ILD was 2.9 months (range: 0.6 to 6 months). Monitor patients for signs and symptoms indicative of pneumonitis/ILD such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis/ILD. Peripheral neuropathy (PN) When PADCEV was given in combination with pembrolizumab, 67% of the 564 patients treated with combination therapy had PN of any grade, 36% had Grade 2 neuropathy, and 7% had Grade 3 neuropathy. The incidence of PN occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of Grade ≥2 PN was 6 months (range: 0.3 to 25 months). PN occurred in 53% of the 720 patients treated with PADCEV as a single agent in clinical trials including 38% with sensory neuropathy, 8% with muscular weakness and 7% with motor neuropathy. Thirty percent of patients experienced Grade 2 reactions and 5% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN. The median time to onset of Grade ≥2 PN was 4.9 months (range: 0.1 to 20 months). Neuropathy led to treatment discontinuation in 6% of patients. Monitor patients for symptoms of new or worsening PN and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade ≥3 PN. Ocular disorders were reported in 40% of the 384 patients treated with PADCEV as a single agent in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry eye symptoms occurred in 30% of patients, and blurred vision occurred in 10% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.7 months (range: 0 to 30.6 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders. Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 1% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions. Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose. ADVERSE REACTIONS Most common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV in combination with pembrolizumab)Increased aspartate aminotransferase (AST), increased creatinine, rash, increased glucose, PN, increased lipase, decreased lymphocytes, increased alanine aminotransferase (ALT), decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection and decreased platelets. Most common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV monotherapy)Increased glucose, increased AST, decreased lymphocytes, increased creatinine, rash, fatigue, PN, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased ALT, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, dry skin. EV-302 Study: 440 patients with previously untreated la/mUC (PADCEV in combination with pembrolizumab)Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab. The most common serious adverse reactions (≥2%) were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Fatal adverse reactions occurred in 3.9% of patients treated with PADCEV in combination with pembrolizumab including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%). Adverse reactions leading to discontinuation of PADCEV occurred in 35% of patients. The most common adverse reactions (≥2%) leading to discontinuation of PADCEV were PN (15%), rash (4.1%) and pneumonitis/ILD (2.3%). Adverse reactions leading to dose interruption of PADCEV occurred in 73% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were PN (22%), rash (16%), COVID‑19 (10%), diarrhea (5%), pneumonitis/ILD (4.8%), fatigue (3.9%), hyperglycemia (3.6%), increased ALT (3%) and pruritus (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 42% of patients. The most common adverse reactions (≥2%) leading to dose reduction of PADCEV were rash (16%), PN (13%) and fatigue (2.7%). EV-103 Study: 121 patients with previously untreated la/mUC who were not eligible for cisplatin-containing chemotherapy (PADCEV in combination with pembrolizumab)Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab; the most common (≥2%) were acute kidney injury (7%), urinary tract infection (7%), urosepsis (5%), sepsis (3.3%), pneumonia (3.3%), hematuria (3.3%), pneumonitis/ILD (3.3%), urinary retention (2.5%), diarrhea (2.5%), myasthenia gravis (2.5%), myositis (2.5%), anemia (2.5%), and hypotension (2.5%). Fatal adverse reactions occurred in 5% of patients treated with PADCEV in combination with pembrolizumab, including sepsis (1.6%), bullous dermatitis (0.8%), myasthenia gravis (0.8%), and pneumonitis/ILD (0.8%). Adverse reactions leading to discontinuation of PADCEV occurred in 36% of patients; the most common (≥2%) were PN (20%) and rash (6%). Adverse reactions leading to dose interruption of PADCEV occurred in 69% of patients; the most common (≥2%) were PN (18%), rash (12%), increased lipase (6%), pneumonitis/ILD (6%), diarrhea (4.1%), acute kidney injury (3.3%), increased ALT (3.3%), fatigue (3.3%), neutropenia (3.3%), urinary tract infection (3.3%), increased amylase (2.5%), anemia (2.5%), COVID‑19 (2.5%), hyperglycemia (2.5%), and hypotension (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 45% of patients; the most common (≥2%) were PN (17%), rash (12%), fatigue (5%), neutropenia (5%), and diarrhea (4.1%). EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy (PADCEV monotherapy)Serious adverse reactions occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each), and pneumonia (5%). Fatal adverse reactions occurred in 3% of patients, including multiorgan dysfunction (1%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis/ILD, and pelvic abscess (0.3% each). Adverse reactions leading to discontinuation occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions leading to dose interruption occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%), and fatigue (9%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite, and fatigue (3% each). EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for cisplatin-based chemotherapy (PADCEV monotherapy)Serious adverse reactions occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis, and diarrhea (5% each). Fatal adverse reactions occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia, and pneumonitis/ILD (1.1% each). Adverse reactions leading to discontinuation occurred in 20% of patients; the most common (≥2%) was PN (7%). Adverse reactions leading to dose interruption occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), increased AST, and hyperglycemia (3% each). Adverse reactions leading to dose reduction occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%), and fatigue (7%). DRUG INTERACTIONSEffects of other drugs on PADCEV (Dual P-gp and Strong CYP3A4 Inhibitors)Concomitant use with dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors. SPECIFIC POPULATIONSLactation Advise lactating women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose. Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment. For more information, please see the U.S. full Prescribing Information including BOXED WARNING for PADCEV here. About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at About Pfizer OncologyAt Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About the Pfizer, Astellas and Merck CollaborationSeagen and Astellas previously entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen's and Astellas' PADCEV™ (enfortumab vedotin) and Merck's KEYTRUDA™ (pembrolizumab) in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Pfizer Disclosure NoticeThe information contained in this release is as of August 12, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and PADCEV™(enfortumab vedotin) in combination with pembrolizumab in cisplatin-ineligible patients with muscle-invasive bladder cancer, including their potential benefits, and plans to submit results from the Phase 3 EV-303 clinical trial for presentation at an upcoming medical congress and to share the Phase 3 EV-303 clinical trial results with the appropriate regulatory authorities to explore potential regulatory filings that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of PADCEV; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed with regulatory authorities in particular jurisdictions for any potential indication for PADCEV with pembrolizumab or as a single agent; whether and when any applications that may be pending or filed for PADCEV with pembrolizumab or as a single agent may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether PADCEV with pembrolizumab or as a single agent will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PADCEV with pembrolizumab or as a single agent; whether the collaboration between Pfizer, Astellas and Merck will be successful; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and _________________________ i World Bladder Cancer Patient Coalition. GLOBOCAN 2022: Bladder cancer 9th most common worldwide. Accessed August 11, 2025. Available at: ii Bladder Cancer Awareness Network. What is Muscle Invasive Bladder Cancer? Accessed August 11, 2025. Available at: iii Esteban-Villarrubia J, Torres-Jiménez J, Bueno-Bravo C, García-Mondaray R, Subiela JD, Gajate P. Current and Future Landscape of Perioperative Treatment for Muscle-Invasive Bladder Cancer. Cancers (Basel). 2023 Jan 17;15(3):566. doi: 10.3390/cancers15030566. PMID: 36765525; PMCID: PMC9913718. iv National Institute of Health. National Library of Medicine. Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/​KEYNOTE-905/​EV-303. identifier: NCT03924895. Published July 24, 2019. Updated June 17, 2025. Accessed August 11, 2025. Available at: v Challita-Eid PM, Satpayev D, Yang P, et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res 2016;76(10):3003-13. vi PADCEV [package insert]. Northbrook, IL: Astellas Pharma US, Inc. View source version on Contacts Pfizer Media Contact:PfizerMediaRelations@ +1-212-733-1226Pfizer Investor Contact:IR@ +1-212-733-4848Astellas Contact:Garrett Corporate Communications+81-3-3244-3202 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

David Caravantes Appointed Executive Director of Beat Cancer Foundation to Lead National Expansion and Outreach Efforts
David Caravantes Appointed Executive Director of Beat Cancer Foundation to Lead National Expansion and Outreach Efforts

Associated Press

time40 minutes ago

  • Associated Press

David Caravantes Appointed Executive Director of Beat Cancer Foundation to Lead National Expansion and Outreach Efforts

Beat Cancer Foundation announces the appointment of David A. Caravantes as Executive Director and CEO, marking a pivotal step forward in the nonprofit's mission 'Knowing all your treatment options could be life-saving,'— says Caravantes SAN DIEGO, CA, UNITED STATES, August 12, 2025 / / -- The Beat Cancer Foundation proudly announces the appointment of David A. Caravantes as Executive Director and CEO, marking a pivotal step forward in the nonprofit's mission to help individuals not only fight cancer - but beat it. With over a decade of experience in strategic communications, nonprofit leadership, and public advocacy, Caravantes brings a bold and inspiring vision to the organization's expanding national footprint. Under his leadership, the Beat Cancer Foundation partnered with OncoSure Testing to launch the revolutionary OncoSure™ cancer screening technology. The foundation plans to scale its outreach programs, broaden access to integrative cancer support, and increase public awareness around early detection, holistic healing, and personalized cancer care. Since its inception, the Beat Cancer Foundation has worked tirelessly to support individuals battling cancer - helping hundreds, including many with stage IV diagnoses, achieve remission and regain their health. As the son of a cancer survivor and a licensed naturopathic practitioner, Caravantes understands firsthand the urgency and hope that define the organization's mission. 'Knowing all your treatment options could be life-saving,' says Caravantes. 'We believe people don't just have to fight cancer - they can beat it,' he adds. 'Our goal is to be the first-place people turn when they're diagnosed, scared, and searching for real answers and support. We're building a global community that believes healing is possible and that cancer doesn't have to be a death sentence.' 'Prevention and early detection are our best weapons against cancer,' Caravantes continues. 'By partnering with OncoSure Testing to deliver OncoSure™, we're ensuring that everyone - regardless of background or income - has access to the fastest, most comprehensive cancer screening available. Detecting cancer before symptoms appear gives people the chance to act early and dramatically improve their chances of survival.' Under Caravantes' leadership, the foundation is launching a multi-channel outreach campaign, including public service podcasts, patient success stories, community education, and partnerships with wellness practitioners, integrative oncologists, and health organizations across the country. About Beat Cancer Foundation The Beat Cancer Foundation (BCF) is a 501(c)(3) nonprofit organization dedicated to helping people prevent, early detect, fight, and overcome cancer by guiding patients toward the safest and most effective treatment options while enhancing their quality of life. BCF serves as a trusted resource on treating cancer as a mitochondrial metabolic disease and empowers individuals through non-toxic, repurposed medications and integrative therapies. With a growing network of survivors, practitioners, and researchers, the Beat Cancer Foundation is committed to offering hope, resources, and real-world strategies that save lives. Media Contact Sarah Jacobs Director of Communications Beat Cancer Foundation 📞 (307) 291-0991 📧 [email protected] 🌐 #BeatCancer #BeatCancerFoundation#EarlyDetection #CancerScreening #AffordableCare #TakeControl #FightCancer #CancerAwareness #HealthcareInnovation David A. Caravantes Beat Cancer Foundation +1 307-291-0991 email us here Visit us on social media: LinkedIn Instagram Facebook YouTube X Other Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

How FDA Drama Is Roiling Biotech Stocks
How FDA Drama Is Roiling Biotech Stocks

Bloomberg

time40 minutes ago

  • Bloomberg

How FDA Drama Is Roiling Biotech Stocks

Hi, all. It's Damian in New York. I've been following a twisty saga at the US's top health regulator that's roiling the trillion-dollar drug industry. But first ... The Food and Drug Administration isn't typically this dramatic. But the controversial appointment, whipsaw resignation, and surprise return of a drug industry provocateur is turning President Donald Trump's FDA into an unknowable quantity in American public health. And that uncertainty has reverberated onto Wall Street, where unpredictability isn't warmly received.

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