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FDA Mandates "Boxed Warning" For Bristol Myers, Johnson & Johnson CAR-T-Based Blood Cancer Therapies
FDA Mandates "Boxed Warning" For Bristol Myers, Johnson & Johnson CAR-T-Based Blood Cancer Therapies
Following an investigation announced in November last year, the FDA said on Thursday that it would now require boxed warnings—the highest safety-related caution for medications—for all chimeric antigen receptor (CAR) T-cell therapies.
According to the agency, these blood cancer treatments may pose a risk of secondary cancers.
The health regulator has required related updates to other label sections, such as warnings and precautions, postmarketing experience, patient counseling information, and medication guides.
The agency said patients and clinical trial participants receiving treatment with these products should be monitored lifelong for secondary malignancies and notify the manufacturer in the event of a new malignancy.
In November, the FDA said it received reports of patients developing T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.
The agency said it's weighing "the need for regulatory action" in response to clinical testing and safety monitoring reports tied to commercial use.
In January, the FDA asked drugmakers to add a boxed warning to their CAR-T cancer therapies.
In its January 19 notification letters, the agency stressed that the potential risk applies to all currently approved CAR-T products.
The regulatory body has mandated label updates for all six commercial CAR-T therapies, including Bristol Myers Squibb & Co's (NYSE:BMY) Abecma (partnered with partner 2seventy bio Inc (NASDAQ: TSVT))and Breyanzi, Johnson & Johnson's (NYSE:JNJ) Carvykti (developed in partnership with Legend Biotech Corporation (NASDAQ: LEGN)), Novartis AG's (NYSE:NVS) Kymriah, and Gilead Sciences Inc's (NASDAQ:GILD) Yescarta.
Gilead's Tecartus was also part of the list, but later, it was removed from boxed warning requirements.
Photo via Shutterstock
Following an investigation announced in November last year, the FDA said on Thursday that it would now require boxed warnings—the highest safety-related caution for medications—for all chimeric antigen receptor (CAR) T-cell therapies.
继去年11月宣布的一项调查之后,美国食品药品管理局周四表示,现在将要求对所有嵌合抗原受体(CAR)T细胞疗法发出盒装警告,这是药物中与安全相关的最高警告。
According to the agency, these blood cancer treatments may pose a risk of secondary cancers.
据该机构称,这些血液癌治疗可能构成继发性癌症的风险。
The health regulator has required related updates to other label sections, such as warnings and precautions, postmarketing experience, patient counseling information, and medication guides.
卫生监管机构已要求对其他标签部分进行相关更新,例如警告和注意事项、上市后经验、患者咨询信息和用药指南。
The agency said patients and clinical trial participants receiving treatment with these products should be monitored lifelong for secondary malignancies and notify the manufacturer in the event of a new malignancy.
该机构表示,应终身监测接受这些产品治疗的患者和临床试验参与者是否存在继发性恶性肿瘤,并在出现新的恶性肿瘤时通知制造商。
In November, the FDA said it received reports of patients developing T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.
美国食品药品管理局在11月表示,它收到了报告,在接受以BCMA或CD19为导向的自体CAR T细胞免疫疗法治疗的患者中,患者出现T细胞恶性肿瘤,包括嵌合抗原受体CAR阳性淋巴瘤。
The agency said it's weighing "the need for regulatory action" in response to clinical testing and safety monitoring reports tied to commercial use.
该机构表示,正在权衡 “监管行动的必要性”,以应对与商业用途相关的临床测试和安全监测报告。
In January, the FDA asked drugmakers to add a boxed warning to their CAR-T cancer therapies.
1月,美国食品药品管理局要求制药商在其CAR-T癌症疗法中添加方框警告。
In its January 19 notification letters, the agency stressed that the potential risk applies to all currently approved CAR-T products.
该机构在1月19日的通知信中强调,潜在风险适用于所有目前批准的CAR-T产品。
The regulatory body has mandated label updates for all six commercial CAR-T therapies, including Bristol Myers Squibb & Co's (NYSE:BMY) Abecma (partnered with partner 2seventy bio Inc (NASDAQ: TSVT))and Breyanzi, Johnson & Johnson's (NYSE:JNJ) Carvykti (developed in partnership with Legend Biotech Corporation (NASDAQ: LEGN)), Novartis AG's (NYSE:NVS) Kymriah, and Gilead Sciences Inc's (NASDAQ:GILD) Yescarta.
监管机构已要求更新所有六种商用CAR-T疗法的标签,包括百时美施贵宝公司(纽约证券交易所代码:BMY)Abecma(与合作伙伴2seventy bio Inc(纳斯达克股票代码:TSVT)合作)和Breyanzi、强生(纽约证券交易所代码:JNJ)Carvykti(与联想生物技术公司(纳斯达克股票代码:LEGN)合作开发)、诺华股份公司(纽约证券交易所代码:NSE: NYSE: NGN)VS)Kymriah和吉利德科学公司(纳斯达克股票代码:GILD)的Yescarta。
Gilead's Tecartus was also part of the list, but later, it was removed from boxed warning requirements.
吉利德的Tecartus也是该清单的一部分,但后来,它被从盒装警告要求中删除。
Photo via Shutterstock
照片来自 Shutterstock
moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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