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.
週五，美國食品藥品管理局批准了百時美施貴寶公司（紐約證券交易所代碼：BMY）和270ty Bio Inc（納斯達克股票代碼：TSVT） Abecma （idecabtagene vicleucel；ide-cel）適用於在先前接受兩條或更多線路治療後復發或難治性多發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.
該批准基於Karmma-3試驗的結果，該試驗顯示，對於癌症復發或對先前至少兩次治療停止反應的患者，Abecma幫助患者將疾病進展前的時間平均延長了13.3個月，而接受標準護理的試驗患者的無進展存活期爲4.4個月。
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.
該批准範圍擴大 Abecma 的 適應症，使在接受這三類主要治療（三類暴露）後復發或出現難治性的患者可以在較早的療程中使用，這些患者在先前接受了兩輪治療後復發或出現難治性。
Abecma is currently approved for adults with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy.
Abecma目前獲准用於在先前接受四種或以上治療後患有三類暴露覆發或難治性多發性骨髓瘤的成年人。
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.
相關： 聚焦百時邁爾斯、吉利德科學、強生、諾華：美國食品藥品管理局將發佈有關血液癌治療CAR-T療法的全班黑箱警告。
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 以一次性輸液方式給藥，新的推薦劑量範圍爲 300 至 510 x 106 個 CAR 陽性 T 細胞。
The FDA pushed the approval date from 16 December 2023.
美國食品和藥物管理局將批准日期從 2023 年 12 月 16 日推遲。
Last month, the FDA's Oncologic Drugs Advisory Committee voted positively (8-3) favoring the expanded use of Abecma.
上個月，美國食品藥品管理局的腫瘤藥物諮詢委員會投了贊成票（8-3），贊成擴大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.
該小組表示，根據關鍵的3期Karmma-3研究結果，包括總生存率的關鍵次要終點，Abecma對三類暴露覆發或難治性多發性骨髓瘤患者表現出良好的益處/風險狀況。
Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome, Neurologic Toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome, Prolonged Cytopenia, and Secondary Hematological Malignancies.
關於細胞因子釋放綜合徵、神經系統毒性、噬血細胞淋巴組織細胞增多症/巨噬細胞活化綜合徵、長期細胞減少和繼發性血液學惡性腫瘤的 Abecma 盒裝警告。
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.
價格走勢：在週五的最後一次支票中，BMY股價下跌0.15％，至51.32美元，TSVT股價上漲3.99％，至5.21美元。
Photo via Shutterstock
照片來自 Shutterstock
譯文內容由第三人軟體翻譯。