FDA Approves Bristol-Myers/2seventy Bio's Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer
FDA Approves Bristol-Myers/2seventy Bio's Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer
Friday, the FDA approved Bristol-Myers Squibb Company (NYSE:BMY) and 2seventy Bio Inc's (NASDAQ:TSVT) Abecma (idecabtagene vicleucel; ide-cel) for adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy.
周五，美国食品药品管理局批准了百时美施贵宝公司（纽约证券交易所代码：BMY）和270ty Bio Inc（纳斯达克股票代码：TSVT） Abecma （idecabtagene vicleucel；ide-cel）适用于在先前接受两条或更多线路治疗后复发或难治性多发性骨髓瘤的成年患者。
The approval is based on results from the KarMMa-3 trial that showed Abecma helped extend the time before disease progression by 13.3 months on average in patients whose cancer has returned or stopped responding to at least two prior treatments compared to 4.4 months progression-free survival seen in trial patients who received standard of care.
该批准基于Karmma-3试验的结果，该试验显示，对于癌症复发或对先前至少两次治疗停止反应的患者，Abecma帮助患者将疾病进展前的时间平均延长了13.3个月，而接受标准护理的试验患者的无进展存活期为4.4个月。
This approval expands Abecma's indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy.
该批准范围扩大 Abecma 的 适应症，使在接受这三类主要治疗（三类暴露）后复发或出现难治性的患者可以在较早的疗程中使用，这些患者在先前接受了两轮治疗后复发或出现难治性。
Abecma is currently approved for adults with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy.
Abecma目前获准用于在先前接受四种或以上治疗后患有三类暴露复发或难治性多发性骨髓瘤的成年人。
Related: Focus On Bristol Myers, Gilead Sciences, Johnson & Johnson, Novartis: FDA To Issue Classwide Black Box Warning on CAR-T Therapies For Blood Cancer Treatment.
相关： 聚焦百时迈尔斯、吉利德科学、强生、诺华：美国食品药品管理局将发布有关血液癌治疗CAR-T疗法的全班黑箱警告。
Abecma is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells.
Abecma 以一次性输液方式给药，新的推荐剂量范围为 300 至 510 x 106 个 CAR 阳性 T 细胞。
The FDA pushed the approval date from 16 December 2023.
美国食品和药物管理局将批准日期从 2023 年 12 月 16 日推迟。
Last month, the FDA's Oncologic Drugs Advisory Committee voted positively (8-3) favoring the expanded use of Abecma.
上个月，美国食品药品管理局的肿瘤药物咨询委员会投了赞成票（8-3），赞成扩大Abecma的使用。
The panel said Abecma demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on the pivotal Phase 3 KarMMa-3 study results, including the key secondary endpoint of overall survival.
该小组表示，根据关键的3期Karmma-3研究结果，包括总生存率的关键次要终点，Abecma对三类暴露复发或难治性多发性骨髓瘤患者表现出良好的益处/风险状况。
Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome, Neurologic Toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome, Prolonged Cytopenia, and Secondary Hematological Malignancies.
关于细胞因子释放综合征、神经系统毒性、噬血细胞淋巴组织细胞增多症/巨噬细胞活化综合征、长期细胞减少和继发性血液学恶性肿瘤的 Abecma 盒装警告。
Price Action: BMY shares are down 0.15% at $51.32, and TSVT shares are up 3.99% at $5.21 on the last check Friday.
价格走势：在周五的最后一次支票中，BMY股价下跌0.15％，至51.32美元，TSVT股价上涨3.99％，至5.21美元。
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