FDA Approves Expanded Use Of Bristol Myers Squibb's Breyanzi Cancer Cell Therapy For Previously Treated Follicular Lymphoma
FDA Approves Expanded Use Of Bristol Myers Squibb's Breyanzi Cancer Cell Therapy For Previously Treated Follicular Lymphoma
Wednesday, the FDA granted accelerated approval to Bristol Myers Squibb Co's (NYSE:BMY) Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for relapsed or refractory follicular lymphoma.
週三，美國食品藥品管理局加速批准了百時美施貴寶公司（紐約證券交易所代碼：BMY） Breyanzi （lisocabtagene maraleucel；liso-cel），一種針對CD19的嵌合抗原受體（CAR）T細胞療法，用於復發或難治性濾泡性淋巴瘤。
This indication is approved under accelerated approval based on response rate and duration of response.
該適應症是根據回覆率和反應持續時間在加速批准下獲得批准的。
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
該適應症的持續批准可能取決於確認性試驗中對臨床益處的驗證和描述。
In April, following an investigation announced in November last year, the FDA said it would now require boxed warnings—the highest safety-related caution for medications—for all chimeric antigen receptor (CAR) T-cell therapies.
繼去年11月宣佈的一項調查之後，美國食品藥品管理局在4月表示，現在將要求所有嵌合抗原受體（CAR）T細胞療法都使用盒裝警告，這是藥物中與安全相關的最高警告。
Related: FDA Approves Bristol-Myers/2seventy Bio's Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer.
相關： 美國食品藥品管理局批准Bristol-Myers/2Seventy Bio的Abecma更早地用於預先治療的血液癌患者，並更新了有關繼發性癌症的方框警告。
Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory follicular lymphoma.
Breyanzi 作爲復發或難治性濾泡性淋巴瘤的三線及後續治療的2A類建議，現已被納入國家綜合癌症網絡（NCCN）的B細胞淋巴瘤腫瘤腫瘤臨床實踐指南（NCCN指南）中。
In relapsed or refractory follicular lymphoma, Breyanzi is delivered as a one-time infusion with a single dose containing 90 to 110 x 10 power 6 CAR-positive viable T cells.
在復發或難治性濾泡性淋巴瘤中， Breyanzi 以一次性輸液的形式輸送，單劑量包含 90 到 110 x 10 功率的 6 個 CAR 陽性活性 T 細胞。
The Phase 2 TRANSCEND FL study included the largest primary analysis set of patients with relapsed or refractory follicular lymphoma of a clinical trial evaluating a CAR T cell therapy in this patient population.
2期TRANSCEND FL研究包括一項評估該患者群體CAR T細胞療法的臨床試驗中對復發或難治性濾泡性淋巴瘤患者的最大初步分析集。
95.7% of patients responded to Breyanzi in the TRANSCEND FL trial.
在TRANSCEND FL試驗中，有95.7％的患者對Breyanzi有反應。
Breyanzi provided sustained clinical benefit with a median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months.
Breyanzi提供了持續的臨床益處，但未達到中位緩解時間，大多數受試者（77.1％）的持續緩解期爲18個月。
Price Action: BMY shares are down 1.38% at $43.94 at last check Thursday.
價格走勢：週四最後一次檢查時，BMY股價下跌1.38％，至43.94美元。
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