Gilead Wins FDA Approval for Trodelvy, Expanding into First-Line Breast Cancer

The U.S. Food and Drug Administration approved Gilead Sciences’ antibody-drug conjugate, Trodelvy, for first-line triple-negative breast cancer.

The approval covers Trodelvy as a monotherapy and in combination with Merck’s Keytruda.

Gilead’s ASCENT clinical trials provided the data supporting this regulatory decision.

The expanded label moves the drug into earlier treatment settings to compete with AstraZeneca and Daiichi Sankyo.