Gilead (GILD) Wins FDA Approval for Trodelvy in TNBC

Gilead Sciences, Inc. (NASDAQ:GILD) is one of the 12 Most Profitable S&P 500 Stocks to Invest In.

On June 25, 2026, the Food and Drug Administration approved Trodelvy from Gilead Sciences, Inc. (NASDAQ:GILD) for two indications in adults with triple-negative breast cancer. The first approval covers sacituzumab govitecan-hziy as a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. The second covers sacituzumab govitecan-hziy in combination with Merck’s (MRK) pembrolizumab, or Keytruda, or pembrolizumab and berahyaluronidase alfa-pmph, or Keytruda Qlex, for first-line treatment in adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 as determined by an FDA-authorized test.

On June 23, Gilead Sciences announced that the European Commission granted marketing authorization for Trodelvy as monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Trodelvy is the first antibody-drug conjugate approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland, and Liechtenstein.

On June 16, Gilead Sciences also said the U.S. FDA accepted its supplemental New Drug Application for Yeztugo 300-mg tablet as a potential once-weekly oral formulation for HIV prevention as pre-exposure prophylaxis. The FDA assigned a Prescription Drug User Fee Act action date of February 2, 2027.

Gilead Sciences, Inc. (NASDAQ:GILD) discovers, develops, and commercializes medicines in areas of unmet medical need in the United States, Europe, and internationally.

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