Gilead: Trodelvy, 1차 mTNBC 적응증 FDA 승인 획득

FDA가 Trodelvy를 단독요법 또는 Keytruda 병용요법으로 1차 치료제로 승인했다. 대상은 절제 불가능한 국소 진행성 또는 전이성 삼중음성유방암 환자다. 라벨은 PD-L1 양성 및 음성 환자 중 면역관문억제제 부적합 환자까지 확대됐다. 이로 인해 적응 가능한 환자군이 늘어나고, 조기 치료 기회가 승인된 적응증으로 전환됐다.

핵심 사실

제출: 2026년 8월 4일 PM 08:03
이벤트: FDA 승인
방향: 긍정적
기업: GILD길리어드 사이언스
자산: sacituzumab govitecan-hziy
출처: SEC 8-K
신뢰도: 출처 확인
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%

출처 발췌

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