Gilead’s Trodelvy Wins FDA Approval for First-Line Breast Cancer, Expanding Market

Gilead Sciences received FDA approval for Trodelvy as a first-line treatment for metastatic triple-negative breast cancer (mTNBC). This approval transitions the drug from a later-line therapy to an initial treatment option. The FDA cleared the drug for use as a standalone therapy or in combination with Merck’s Keytruda.

Trial data showed Trodelvy-based regimens significantly reduced the risk of disease progression or death. This label expansion positions Gilead to compete directly with a rival drug from AstraZeneca and Daiichi Sankyo. The first-line designation is vital because many patients with aggressive mTNBC do not survive to receive later-line treatments.