Gilead: Trodelvy, FDA'dan 1L mTNBC onayı aldı

FDA, Trodelvy'yi PD-L1-pozitif ve PD-L1-negatif, kontrol noktası inhibitörlerine uygun olmayan hastalar için birinci basamak rezeke edilemeyen lokal ileri veya metastatik üçlü negatif meme kanserinde monoterapi veya Keytruda ile kombinasyon halinde onayladı. Bu onay, hedef hasta popülasyonunu genişletiyor ve daha erken basamak bir fırsatı onaylanmış bir kullanıma dönüştürüyor.

Temel olgular

Bildirildi: 4 Ağu 2026 20:03
Olay: FDA onayı
Yön: Olumlu
Şirket: GILDGilead
Varlık: sacituzumab govitecan-hziy
Kaynak: SEC 8-K
Güvenilirlik: Kaynaklı
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%

Kaynak alıntısı

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