Breyanzi的sBLA獲受理,復發/難治性邊緣區淋巴瘤的PDUFA日期為2025年12月5日

FDA 已受理 Breyanzi 用於復發/難治性邊緣區淋巴瘤（≥2 線先前治療）的補充 BLA 申請，並授予優先審查。該機構將 PDUFA 目標日期定為 2025 年 12 月 5 日，為此新適應症確立了近期的監管決策時點。

關鍵事實

申報時間: 2025年10月30日上午11:09
事件: 申請已受理
方向: 正面
公司: BMY必治妥施貴寶
資產: lisocabtagene maraleucel
來源: SEC 8-K
可信度: 有出處
行事曆: FDA 審查決定 (PDUFA) · 2025年12月5日 · 結果未記錄

來源摘錄

EX-99.1 2 a2025q3ex991.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED OCTOBER 30, 2025 Document Exhibit 99.1 Bristol Myers Squibb Reports Third Quarter Financial Results for 2025 Performance Marked by Continued Growth Portfolio Momentum, Pipeline Advancements and Strategic Business Development • Third quarter revenues increased 3% (+2% Ex-FX) to $12.2 billion ◦ Growth Portfolio revenues increased 18% (+17% Ex-FX) to $6.9 billion • GAAP EPS was $1.08 and non-GAAP EPS was $1.63; Both figures include net impact of $(0.20) due to the Acquired IPRD charges and licensing income • Raising 2025 revenue guidance to a range of ~$47.5 billion to $48.0 billion; Updating non-GAAP EPS range to $6.40 to $6.60, inclusive of an $(0.80) per share net impact from Acquired IPRD charges and licensi

SEC 8-K