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原始出處紀錄

決策級FDA 核准

吉利德：Trodelvy 獲得 FDA 一線 mTNBC 核准

FDA 已核准 Trodelvy 作為單一療法或與 Keytruda 合併用於一線不可切除局部晚期或轉移性三陰性乳癌。標籤現涵蓋 PD-L1 陽性及 PD-L1 陰性且不適合使用 checkpoint inhibitor 的患者。此舉擴大目標族群，並將早期治療機會轉為核准適應症。

關鍵事實

申報時間
2026年8月4日 下午08:03
事件
FDA 核准
方向
正面
公司
GILD吉利德
資產
sacituzumab govitecan-hziy
來源
SEC 8-K
可信度
有出處
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%

來源摘錄

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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