Latest news with #HodgkinLymphoma
Daily Mail
13 hours ago
- Health
- Daily Mail
Premier League footballer who beat cancer reveals he's expecting his first child in emotional announcement on social media
David Brooks cried tears of joy after being told he is to become a dad — something the Wales forward feared might not happen following his 2021 cancer diagnosis. The Bournemouth winger's wife Flora revealed last weekend she is pregnant, with the pair expecting their first baby in November. It is the news the couple thought would never come. Brooks was diagnosed with stage-two Hodgkin lymphoma nearly four years ago and, although he announced he was cancer-free in May 2022, the long-term effects of the disease in terms of fathering children were unclear. So, it was with the upmost joy that Flora shared a video on Instagram on Sunday showing a sonogram of the couple's imminent arrival alongside a Bournemouth shirt with 'Daddy' printed on the back. 'Obviously when I was diagnosed you have those conversations and there were never any guarantees that I would be able to have children in the future,' said Brooks, who has linked up with the Wales squad for their World Cup qualifying double header against Liechtenstein and Belgium. 'There was a chance it wouldn't have been possible and I was really lucky that it came naturally. After my treatment things went back to normal so, of course, I was really happy. 'We were trying so it wasn't a massive shock, but there were a few tears. 'We always wanted kids at some point, but the situation kind of took it out of hands a little bit. 'So it's obviously very nice for everything to come naturally and progress into being a family. 'We're really looking forward to it, even though she is going through everything that comes with being pregnant.' Brooks was the Wales hero in their last World Cup qualifier against North Macedonia in March. His equaliser in the sixth minute of stoppage time secured a precious 1-1 draw, making it four points from the opening two qualifiers and extending Craig Bellamy's unbeaten start as Dragons manager to eight games. 'I think it instils a little bit of fear into who we are playing,' said Brooks. 'They know we are not going to give up, even if it's the 96th minute. It's a massive positive. 'If felt like a big goal in North Macedonia and it makes the table looks a lot better for us. I feel like we are on a good journey.' Brooks says he is now in the 'old box' at 27 with the Wales squad having changed so much in recent years. Gareth Bale and Joe Allen are retired and captain Aaron Ramsey, the third standout member of the team which reached the semi-finals of Euro 2016, is recovering from another injury setback. Brooks said: 'This is probably the first campaign we have had without them. 'There's a lot of young talent coming through and a lot of lads, including myself, who have been waiting for an opportunity to showcase ourselves.
The Independent
a day ago
- Health
- The Independent
There were a few tears – Wales forward David Brooks expecting first child
David Brooks cried tears of joy after being told he is to become a dad – something the Wales forward feared might not happen following his 2021 cancer diagnosis. Brooks, who was diagnosed with stage-two Hodgkin lymphoma nearly four years ago, and wife Flora are expecting their first child on November 1. The 27-year-old Bournemouth player announced he was cancer-free in May 2022, but the long-term effects of the disease in terms of fathering children were unclear. 'Obviously when I was diagnosed you have those conversations and there were never any guarantees that I would be able to have children in the future,' said Brooks, who has linked up with the Wales squad for their World Cup qualifying double header against Liechtenstein and Belgium. 'There was a chance it wouldn't have been possible and I was really lucky that it came naturally. After my treatment things went back to normal so, of course, I was really happy. 'We were trying so it wasn't a massive shock, but there were a few tears. 'We always wanted kids at some point, but the situation kind of took it out of hands a little bit. 'So it's obviously very nice for everything to come naturally and progress into being a family. 'We're really looking forward to it, even though she is going through everything that comes with being pregnant.' Brooks was the Wales hero in their last World Cup qualifier against North Macedonia in March. His equaliser in the sixth minute of stoppage time secured a precious 1-1 draw, making it four points from the opening two qualifiers and extending Craig Bellamy's unbeaten start as Dragons manager to eight games. 'I think it instils a little bit of fear into who we are playing,' said Brooks. 'They know we are not going to give up, even if it's the 96th minute. It's a massive positive. 'If felt like a big goal in North Macedonia and it makes the table looks a lot better for us. I feel like we are on a good journey.' Brooks says he is now in the 'old box' at 27 with the Wales squad having changed so much in recent years. Gareth Bale and Joe Allen are retired and captain Aaron Ramsey, the third standout member of the team which reached the semi-finals of Euro 2016, is recovering from another injury setback. Brooks said: 'This is probably the first campaign we have had without them. 'There's a lot of young talent coming through and a lot of lads, including myself, who have been waiting for an opportunity to showcase ourselves. 'We are all looking as a collective to try to move forward, instead of it being about the special individual.'
BBC News
a day ago
- Sport
- BBC News
'There were tears, but we are looking forward to it'
World Cup qualifier: Wales v LiechtensteinVenue: Cardiff City Stadium Date: Friday, 6 June Kick off: 19:45 BSTCoverage: Live on BBC One Wales, S4C, iPlayer, BBC Radio Wales and Radio Cymru, the BBC Sport website and app, plus live text commentary. David Brooks took the plaudits when Wales players were last together in March after scoring the 96th-minute equaliser in North Macedonia which preserved Craig Bellamy's unbeaten record as head were more congratulations for Brooks when the Wales squad reconvened for World Cup qualifiers against Liechtenstein and Belgium this week, but for entirely different and wife Flora revealed on social media earlier this week that they are to become parents, with their baby due on 1 Brooks, who was diagnosed with cancer in 2021, the news is especially joyous given that there were questions about whether this time would ever come."I always wanted to start a family. My wife and I wanted kids at some point," the 27-year-old says."Obviously when I was diagnosed, you have those conversations and there were never any guarantees that I would be able to have children in the future. There was a chance it wouldn't have been possible."But I was really lucky that it came naturally. After my treatment things went back to normal, so of course I was really happy. There were a few tears, but we are really looking forward to it."Brooks was 24 when he was diagnosed with Stage Two Hodgkin lymphoma in October were "dark times" for the attacking midfielder but, after several months of chemotherapy, he was declared cancer free in May returned to first-team football with Bournemouth in March 2023 and was back in the Wales squad that summer. A senior figure Two years on, Brooks acknowledges that he is now one of Wales' "more senior lads".Joe Allen's retirement means another of the nation's greats has gone, while captain Aaron Ramsey is again missing from this camp due to who has 33 caps, says he relishes the responsibility that comes with being one of the more experienced players in a squad which is rebuilding having lost the likes of Allen, Chris Gunter and Gareth Bale since the 2022 World Cup."Bale is probably the best British player of all time and Joe Allen has been one of the best Welsh players of all time," he adds"They are obviously are a big miss, but there's a lot of young talent coming through and there are a lot of lads, including myself, who have been waiting for an opportunity to showcase ourselves."This is probably the first campaign we have had without them. We are all looking as a collective to try to move forward instead of it being about the special individual. I think we are doing a good job." 'It felt like a big goal' Wales will expect to make it nine games without defeat since Bellamy took charge when the minnows of Liechtenstein visit the Cardiff City Stadium on a sterner challenge awaits in Brussels next Monday, when Wales tackle Group J's top seeds unbeaten record looked set to go during the previous international camp, when North Macedonia went ahead in added time in Skopje only for Brooks to prod home his fifth international goal with almost the last kick of the game."It was not one of my best but as long as it trickles over the line, I am not too fussed," he says."If felt like a big goal in North Macedonia and it makes the table looks a lot better for us."Wales are second as things stand, behind North Macedonia on goal difference, although Belgium are yet to play a game in the Red Devils go to North Macedonia on Friday before returning home to meet Wales. In years gone by, Wales may have viewed a trip to a heavyweight nation like Belgium with some trepidation, as a fixture where a draw would be a superb under Bellamy, who rejects the notion of his side being underdogs, Wales will travel with expectation rather than mere echoes team-mates by describing Bellamy's approach as "intense" – but says Wales' players are hungry to deliver for their boss."He is obviously a very, very passionate guy, especially about Wales, and that can't be a negative," Brooks adds."We want to play well for him and play in his system. We have had a good base, going unbeaten so far, and now we are looking to build on that and become more of a threat and minimising our risk of conceding goals."I feel like we are on a good journey."
National Post
3 days ago
- Business
- National Post
European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Newly Diagnosed Stage IIb/III/IV Hodgkin Lymphoma in Combination with ECADD
Article content Article content – Second Approval in Frontline Hodgkin Lymphoma Broadens ADCETRIS' Therapeutic Reach, Adding to Six Previously Approved, Distinct Indications for ADCETRIS in the European Union Article content OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved ADCETRIS ® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025. Article content The approval for this ADCETRIS-based combination regimen, known as BrECADD, in frontline Hodgkin lymphoma is based on the results of the randomized Phase 3 HD21 trial. The study met its co-primary safety and efficacy endpoints, with BrECADD demonstrating significantly superior safety as assessed by treatment-related morbidity (TRMB) and non-inferior progression-free survival (PFS) in comparison to escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone (eBEACOPP), a standard of care treatment in Europe 1. Article content 'Today's approval represents a significant advancement for patients with Hodgkin lymphoma in the European Union,' said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. 'This approval reinforces the role of ADCETRIS as a backbone in the treatment of specific lymphomas, offering healthcare professionals greater flexibility to tailor treatment plans according to individual patient needs. We're proud to contribute another impactful option for those diagnosed with this challenging disease.' Article content ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in the European Union (EU) in six distinct indications. This decision marks the second approval for an ADCETRIS-based combination regimen for frontline Hodgkin lymphoma, broadening the spectrum of available treatments for patients who historically have had limited options. Article content 'With BrECADD, patients now have a treatment option that not only offers greater curative potential 2* but also significantly reduces treatment-related morbidity compared to eBEACOPP,' said Peter Borchmann, MD, PhD, University Hospital of Cologne, Germany, and trial chairman of the HD21 study. 'This new ADCETRIS-based combination therapy may offer a new standard of care for frontline treatment of adults with advanced stage Hodgkin lymphoma, contributing to improved long-term outcomes for patients.' Article content About the HD21 Trial The HD21 study is a Phase 3, multi-country, prospective, open-label, randomized, multicenter trial conducted by the German Hodgkin Study Group (GHSG) with a PET-response adapted designed to assess the feasibility, efficacy, safety and tolerability of BrECADD, a novel, rationally designed, CD30-intensified frontline regimen for patients with advanced Hodgkin lymphoma. Article content Enrolled patients with newly diagnosed, Stage IIb with large mediastinal mass and/or extranodal lesions, Stage III or IV Hodgkin lymphoma were randomized to receive two cycles of either escalated BEACOPP or BrECADD, respectively, followed by interim PET staging. A decision is then made if patients received a further two or four cycles of escalated BEACOPP or BrECADD. Article content The HD21 trial aims to evaluate a new treatment regimen to minimize side effects, while maintaining similar responses to treatment. The study has co-primary endpoints: safety is assessed by treatment-related morbidity (TRMB) (superiority), a novel endpoint focused on clinically relevant, acute toxicities of primary chemotherapy, and efficacy is assessed by PFS (non-inferiority). Secondary endpoints are tumor response (complete response [CR] rate), overall survival (OS), infertility rate at one year, second malignancies, frequency of adverse events, therapy adherence and quality of life. Article content About ADCETRIS® (brentuximab vedotin) ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Pfizer's proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells. Article content ADCETRIS injection for intravenous infusion has received FDA approval for eight indications: Article content Adult patients with previously untreated Stage III/IV classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vinblastine, and dacarbazine (2018) Pediatric patients 2 years and older with previously untreated high risk cHL in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide (2022) Adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation (2015) Adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates (2011) Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (2018) Adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen (2011) Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) after prior systemic therapy (2017) Adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or CAR T-cell therapy, in combination with lenalidomide and a rituximab product (2025) Article content Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019. Article content ADCETRIS received conditional marketing authorization from the European Commission in October 2012, and the specific obligations of the conditional marketing authorization were fulfilled in May 2022. The approved indications in the European Union are: (1) for the treatment of adult patients with previously untreated CD30-positive Stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD), (2) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (3) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (4) for the treatment of adult patients with relapsed or refractory sALCL, (5) for the treatment of adult patients with previously untreated sALCL in combination with CHP, (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (7) for the treatment of adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD). Article content ADCETRIS has received marketing authorization by regulatory authorities in 80 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See Important Safety Information below. ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies. Article content Pfizer and Takeda fund joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Article content ADCETRIS (brentuximab vedotin) Important Safety Information (European Union) Please refer to Summary of Product Characteristics (SmPC) before prescribing. Article content Contraindications ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. Combined use of bleomycin and ADCETRIS causes pulmonary toxicity. Article content Special Warnings and Precautions Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Article content Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in PML and death can occur in ADCETRIS-treated patients. PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal. Article content Patients should be closely monitored for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. ADCETRIS should be held for any suspected case of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established. ADCETRIS dosing should be permanently discontinued if a diagnosis of PML is confirmed. Article content The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms). Article content Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Article content Patients should be closely monitored for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. ADCETRIS should be held for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed. Article content Pulmonary Toxicity: Cases of pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), some with fatal outcomes, have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. In the event of new or worsening pulmonary symptoms (e.g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients should be treated appropriately. Consider holding ADCETRIS dosing during evaluation and until symptomatic improvement. Article content Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections. Article content Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have been reported with ADCETRIS. Article content Patients should be carefully monitored during and after infusion. If an anaphylactic reaction occurs, administration of ADCETRIS should be immediately and permanently discontinued and appropriate medical therapy should be administered. Article content If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. Premedication may include paracetamol, an antihistamine and a corticosteroid. Article content IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin. Article content Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumour and high tumour burden are at risk of tumour lysis syndrome. These patients should be monitored closely and managed according to best medical practice. Management of TLS may include aggressive hydration, monitoring of renal function, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care. Article content Peripheral neuropathy (PN): ADCETRIS may cause peripheral neuropathy, both sensory and motor. ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases. In clinical trials, the majority of patients had resolution or improvement of their symptoms. Patients should be monitored for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paraesthesia, discomfort, a burning sensation, neuropathic pain or weakness. Patients experiencing new or worsening peripheral neuropathy may require a delay and a dose reduction of ADCETRIS or discontinuation of treatment. Article content Hematological toxicities: Grade 3 or Grade 4 anaemia, thrombocytopenia, and prolonged (≥ 1 week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose. Article content Febrile neutropenia: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection with an absolute neutrophil count < 1.0 x 10 9 /L, fever ≥ 38.5 0 C; ref CTCAE v3) has been reported with treatment with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment. Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops. Article content In combination therapy with AVD or CHP, advanced age was a risk factor for febrile neutropenia. When ADCETRIS is administered in combination with AVD or CHP, primary prophylaxis with G-CSF, beginning with the first dose, is recommended for all adult patients regardless of age. In combination therapy with AVD or CHP, advanced age was a risk factor for febrile neutropenia. Article content Severe cutaneous adverse reactions (SCARs): Cases of SCARs, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with ADCETRIS. Fatal outcomes have been reported for SJS and TEN. If SJS, TEN or DRESS occur, ADCETRIS should be discontinued, and appropriate medical therapy should be administered. Article content Gastrointestinal (GI) Complications: GI complications including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, some with fatal outcomes, have been reported in patients treated with ADCETRIS. In the event of new or worsening GI symptoms, perform a prompt diagnostic evaluation and treat appropriately. Article content Hepatotoxicity: Hepatotoxicity in the form of elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) has been reported with ADCETRIS. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk. Liver function should be tested before initiating the treatment and routinely monitored in patients receiving ADCETRIS. Patients experiencing hepatotoxicity may require a delay, change in dose or discontinuation of ADCETRIS. Article content Hyperglycemia: Hyperglycaemia has been reported during clinical trials in patients with an elevated Body Mass Index (BMI) with or without a history of diabetes mellitus. However, any patient who experiences an event of hyperglycaemia should have their serum glucose closely monitored. Anti-diabetic treatment should be administered as appropriate. Article content Infusion site extravasation: Extravasation during intravenous infusion has occurred. Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration. Article content Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations. Article content CD30+ CTCL: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence. In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology. These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes. Nevertheless, ADCETRIS should be used with caution in other CD30+ CTCL patients after careful consideration of the potential benefit-risk on an individual basis. Article content Sodium content in excipients: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Article content Polysorbate content in excipients: This medicinal product contains 2 mg of polysorbate 80 per vial, equivalent to 0.2 mg/ml. Polysorbates may cause allergic reactions. Article content Interactions Interaction with medicinal products metabolised through CYP3A4 route (CYP3A4 inhibitors/inducers) Co‑administration of brentuximab vedotin with ketoconazole, a strong CYP3A4 and P‑gp inhibitor, increased the exposure to the antimicrotubule agent MMAE by approximately 73%, and did not alter the plasma exposure to brentuximab vedotin. Therefore, co‑administration of brentuximab vedotin with strong CYP3A4 and P‑gp inhibitors may increase the incidence of neutropenia. If neutropenia develops, refer to Tables 1 and 2 for dosing recommendations for neutropenia. Article content Co‑administration of brentuximab vedotin with rifampicin, a strong CYP3A4 inducer, did not alter the plasma exposure to brentuximab vedotin. Though PK data are limited, co‑administration of rifampicin appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. Article content Co‑administration of midazolam, a CYP3A4 substrate, with brentuximab vedotin did not alter the metabolism of midazolam; therefore brentuximab vedotin is not expected to alter the exposure to medicines that are metabolized by CYP3A4 enzymes. Article content Etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD regimen) The pharmacokinetics of ADC and MMAE have not been characterized in the setting of BrECADD. Exposures of brentuximab vedotin and concurrent chemotherapy are not expected to be affected in the BrECADD regimen. Article content Fertility, pregnancy and lactation Women of childbearing potential: Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. Article content Pregnancy: There are no data from the use of ADCETRIS in pregnant women. Studies in animals have shown reproductive toxicity. ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus. If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the fetus. Article content Breast-feeding: There is no data as to whether brentuximab vedotin or its metabolites are excreted in human milk. A risk to the newborn/infant cannot be excluded. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy, taking into account a potential risk of breast-feeding for the child and the benefit of therapy for the woman. Article content Fertility: In non-clinical studies, brentuximab vedotin treatment has resulted in testicular toxicity, and may alter male fertility. MMAE has been shown to have anagenic properties. Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment. Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose. Article content Effects on ability to drive and use machines: ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness). Article content Undesirable Effects Monotherapy: The most frequent adverse reactions (≥10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnea, weight decreased, myalgia and abdominal pain. Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was ≤1%. Adverse events led to treatment discontinuation in 24% of patients. Article content Combination Therapy: In the studies of ADCETRIS as combination therapy in 662 patients with previously untreated advanced HL and 223 patients with previously untreated CD30+ PTCL, the most common adverse reactions (≥ 10%) were: infections, neutropenia, peripheral sensory neuropathy, nausea, constipation, vomiting, diarrhea, fatigue, pyrexia, alopecia, anemia, weight decreased, stomatitis, febrile neutropenia, abdominal pain, decreased appetite, insomnia, bone pain, rash, cough, dyspnea, arthralgia, myalgia, back pain, peripheral motor neuropathy, upper respiratory tract infection, and dizziness. In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 34% of patients. Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (15%), pyrexia (5%), and neutropenia (3%). Adverse events led to treatment discontinuation in 10% of patients. Article content In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 34% of patients. Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (15%), pyrexia (5%), and neutropenia (3%). Adverse events led to treatment discontinuation in 10% of patients. Article content Adverse events led to treatment discontinuation in 10% of patients. Adverse events that led to treatment discontinuation in ≥ 2% of patients included peripheral sensory neuropathy, and peripheral neuropathy. Article content Combination Therapy (BrECADD regimen): In the HD21 study, 747 patients received BrECADD, and 741 patients received eBEACOPP. The safety profile of ADCETRIS in patients receiving BrECADD remained consistent with other combination therapy (AVD/CHP). Article content Serious adverse reactions occurred in 39.4% patients receiving BrECADD treatment, and 36.4% in patients who received eBEACOPP. The most common serious adverse reactions in patients who received BrECADD (> 3%) were febrile neutropenia (19.3%), pyrexia (3.9%), and neutropenia (3.2%). Article content Serious cardiac adverse reactions occurred in 2.7% of patients receiving BrECADD and 1.1% of patients receiving eBEACOPP. The most common serious cardiac adverse reaction in patients who received BrECADD (>0.5%) was tachycardia (0.9%). Article content Serious adverse events led to treatment discontinuation in 2% of patients in both BrECADD and eBEACOPP arms. The most common serious adverse events that led to discontinuation in the BrECADD arm were febrile neutropenia (0.3%) and cardiac failure (0.3%). Article content CONTRAINDICATION Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation). Article content Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay, change in dose, or discontinuation of ADCETRIS. Article content Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid. Article content Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS. Article content Administer G-CSF primary prophylaxis beginning with Cycle 1 for adult patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL, and pediatric patients who receive ADCETRIS in combination with chemotherapy for previously untreated high risk cHL. Article content Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses. Article content Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for infections. Article content Tumor lysis syndrome: Patients with rapidly proliferating tumor and high tumor burden may be at increased risk. Monitor closely and take appropriate measures. Article content Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment. Avoid use in patients with severe renal impairment. Article content Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment. Avoid use in patients with moderate or severe hepatic impairment. Article content Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS. Article content PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed. Article content Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement. Article content Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy. Article content Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with pre-existing GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately. Article content Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated. Article content Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of this potential risk, and to use effective contraception during ADCETRIS treatment and for 2 months after the last dose of ADCETRIS. Advise male patients with female partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS. Article content ADVERSE REACTIONS The most common adverse reactions (≥20%) in adult patients are peripheral neuropathy, nausea, fatigue, musculoskeletal pain, constipation, diarrhea, vomiting, pyrexia, upper respiratory tract infection, mucositis, abdominal pain, and rash. The most common laboratory abnormalities (≥20%) in adult patients are decreased neutrophils, increased creatinine, decreased hemoglobin, decreased lymphocytes, increased glucose, increased ALT, and increased AST. Article content The most common Grade ≥3 adverse reactions (≥5%) in combination with AVEPC in pediatric patients were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection. Article content DRUG INTERACTIONS Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions. Article content Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here. Article content About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Article content Important Notice For the purposes of this notice, 'press release' means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ('Takeda') regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Article content Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. 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These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Article content Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Article content Footnotes: Article content *While late relapse is rare, PFS status after 5 years does not guarantee cure. Patients should be monitored and encouraged to report any return of symptoms as appropriate. Article content References: Article content Borchmann P, Ferdinandus J, Schneider G, et al. Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): a randomised, multicentre, parallel, open-label, phase 3 trial [published correction appears in Lancet. 2024 Nov 30;404(10468):2164. doi: 10.1016/S0140-6736(24)02571-6.]. Lancet. 2024;404(10450):341-352. Bröckelmann PJ, Goergen H, Kohnhorst C, von Tresckow B, Moccia A, Markova J, Meissner J, Kerkhoff A, Ludwig WD, Fuchs M, Borchmann P, Engert A. Late Relapse of Classical Hodgkin Lymphoma: An Analysis of the German Hodgkin Study Group HD7 to HD12 Trials. J Clin Oncol. 2017 May 1;35(13):1444-1450. doi: 10.1200/JCO.2016.71.3289. Epub 2017 Feb 27. PMID: 28240973. Article content Article content Article content Article content Article content Contacts Article content Takeda Media Contacts: Japanese Media Tsuyoshi Tada Article content Article content
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29-05-2025
- Health
- Yahoo
Sperm Donor With Rare Mutation Linked to Cancer Sparks Debate
Originally appeared on E! Online A sperm donor with a rare genetic mutation linked to cancer is sparking debate about regulation of the practice. In the years between 2008 and 2015, sperm from the same donor was used to conceive at least 67 children from 46 families, Edwige Kasper—a biologist at Rouen University Hospital in France—revealed, per CNN, during a May 24 presentation at the annual conference of the European Society of Human Genetics in Milan. And of the children conceived using the unnamed donor's sperm, ten have already been diagnosed with cancer. 'At the heart of the problem seems to lie the regulation,' Kasper explained during the presentation, 'or maybe the lack of regulation of the number of births by a single donor.' While analysis proved that the donor was healthy himself, it also showed that he possessed a rare mutation in a gene named TP53, which is likely to cause a rare disorder that increases a person's risk of developing cancer called Li-Fraumeni Syndrome. More from E! Online Justin Bieber Reacts to Wife Hailey Bieber's $1 Billion Beauty Deal Savannah Chrisley Reunites With Todd Chrisley in Florida After Prison Release Eddie Murphy's Son Eric and Martin Lawrence's Daughter Jasmin Are Married The mutation was not known when the donation was made, Kasper clarified, but children born from this donor have since been identified in eight different European countries. And ten of them have been diagnosed with cancers such as brain tumors and Hodgkin Lymphoma. Another 13 children, per CNN, are carrying the gene but have not yet developed a cancer. Because of the children's increased risk of developing cancer, Kasper added that they will require regular medical examinations throughout their lifetimes. After all, they have been predisposed to have a 50% chance of transmitting the mutation onto their kids. At the time of donation, the man had only donated to a single private sperm bank, per CNN, The European Sperm Bank in Denmark. 'The donor has been thoroughly tested even above the required standards,' Julie Paulli Budtz, the organization's Vice President of Corporate Communications, told CNN in a statement. 'But preventative genetic screening is reaching its limits here.' 'Every human being has about 20,000 genes,' she added, 'and it is scientifically simply not possible to detect disease-causing mutations in a person's gene pool if you don't know what you are looking for.' And while there is currently no limit on the number of children that are allowed to be born using a single donor, per CNN, Budtz expressed her desire to change that. 'In addition to following national pregnancy limits,' she stated, 'we have proactively implemented our own international limit of 75 families per donor.' For the latest breaking news updates, click here to download the E! News App
