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原始来源记录

决策级FDA 批准

吉利德：Trodelvy 获得 FDA 一线 mTNBC 批准

FDA 已批准 Trodelvy 作为单药或与 Keytruda 联合用于一线不可切除的局部晚期或转移性三阴性乳腺癌。该标签现涵盖 PD-L1 阳性和 PD-L1 阴性且不适合使用检查点抑制剂的患者。这扩大了可及人群，并将更早期的治疗机会转化为获批适应症。

关键事实

申报时间
2026年8月4日 20:03
事件
FDA 批准
方向
积极
公司
GILD吉利德
资产
sacituzumab govitecan-hziy
来源
SEC 8-K
可信度
有来源
median DOR asc3
12.2 vs 7.2 months
median DOR asc4
16.5 vs 9.2 months
patients treated
>75,000
PFS risk reduction asc3
38%
PFS risk reduction asc4
35%

来源摘录

EX-99.1 2 exhibit991earningspressrel.htm EXHIBIT 99.1 Document GILEAD SCIENCES ANNOUNCES SECOND QUARTER 2026 FINANCIAL RESULTS Product Sales Excluding Veklury Increased 10% Year-Over-Year to $7.6 billion Biktarvy Sales Increased 7% Year-Over-Year to $3.8 billion Diluted Loss Per Share was $(8.45) and Non-GAAP Diluted Loss Per Share was $(6.75) Reflecting $(9.08) Per Share Acquired IPR&D and Tax Expenses Associated with Recent Acquisitions Foster City, CA, August 4, 2026 - Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the second quarter 2026. “Gilead delivered a very strong second quarter, with 10% year-over-year revenue growth in our base business driven by our HIV portfolio, Trodelvy and Livdelzi. HIV sales grew 12%, reflecting continued strength in

SEC 8-K

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