GILD · 8-K · 20260804PR000028

Oncology Product Expansion

GILEAD SCIENCES, INC. · 2026-08-04 · Importance 31 · Surprise 42

Gilead received FDA approval for Trodelvy in first-line unresectable locally advanced or metastatic triple-negative breast cancer. The approval covers monotherapy for patients who are not candidates for PD-1/PD-L1 inhibitor therapy and combination use with Keytruda or Keytruda Qlex for tumors expressing PD-L1. The European Commission authorized Trodelvy monotherapy for first-line metastatic triple-negative breast cancer, and the European Medicines Agency issued a positive opinion for the Keytruda combination. Gilead discontinued the Phase 3 EVOKE-03 study in first-line metastatic non-small cell lung cancer after an external Data Monitoring Committee review of progression-free and interim overall-survival data.