Gilead: Trodelvy obtiene la aprobación de la FDA para 1L mTNBC

La FDA aprobó Trodelvy como monoterapia o con Keytruda para el cáncer de mama triple negativo localmente avanzado o metastásico irresecable en primera línea. La etiqueta ahora cubre tanto a pacientes PD-L1-positivos como PD-L1-negativos no elegibles para inhibidores de puntos de control. Esto amplía la población abordable y convierte una oportunidad de línea anterior en un uso aprobado.

Datos clave

Presentado: 4 ago 2026, 20:03
Evento: Aprobación de la FDA
Dirección: Positivo
Empresa: GILDGilead
Activo: sacituzumab govitecan-hziy
Fuente: SEC 8-K
Confianza: Con fuente
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%

Extracto de la fuente

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