Gilead's Trodelvy Expands Reach With New FDA Approval In Breast Cancer - Merck & Co (NYSE:MRK), Gilead Sc

The U.S.

Food and Drug Administration on Wednesday approved Gilead Sciences Inc.'s (NASDAQ:GILD) Trodelvy (sacituzumab govitecan-hziy) for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC), significantly expanding the drug's role in first-line treatment.

Under the expanded label, Trodelvy can now be used as a standalone treatment in first-line mTNBC patients who are not eligible for PD-(L)1 inhibitor-based therapy.

The drug is also approved in combination with Merck & Co Inc.'s (NYSE:MRK) Keytruda (pembrolizumab) or Keytruda Qlex for patients whose tumors express PD-L1 with a combined positive score of at least 10.

Read Also: Gilead And Merck End Trodelvy-Keytruda Lung Cancer Trial Phase 3 Studies Show Significant Reduction In Disease Progression Risk The approval was supported by data from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 studies.