Gilead's Trodelvy Gains EU Approval for Breast Cancer

The European Commission has granted marketing authorization for Gilead Sciences' Trodelvy. This approval is for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not previously undergone systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy.

This significant development makes Trodelvy the first antibody-drug conjugate to receive approval in the European Union for first-line metastatic TNBC. The authorization covers the EU's 27 member states, plus Norway, Iceland, and Liechtenstein.

In parallel, Gilead Sciences announced on June 16, 2026, that the U.S. Food and Drug Administration accepted its supplemental New Drug Application for Yeztugo. This seeks approval for a 300-mg tablet intended for once-weekly oral administration for HIV prevention as pre-exposure prophylaxis. The FDA has set a Prescription Drug User Fee Act action date of February 2, 2027, for this application.

Previously, on June 25, 2026, the FDA had approved Trodelvy for two indications in adults with TNBC. These cover sacituzumab govitecan-hziy as a single agent for first-line treatment in specific TNBC patients, and in combination with Merck's pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for certain first-line treatments.