FOSTER CITY (dpa-AFX) - Gilead Sciences Inc. (GILD) on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for Trodelvy as a first-line treatment for adults with unresectable locally advanced or metastatic triple-negative breast cancer.
A decision from the European Commission is expected later this year.
The recommendation was based on data from the Phase 3 ASCENT-03 study, which showed statistically significant and clinically meaningful progression-free survival benefits for Trodelvy compared with standard chemotherapy as a first-line treatment.
Gilead also said it has submitted an application to the U.S. Food and Drug Administration seeking approval of Trodelvy for the indication.
In addition, the company has submitted supplemental applications to the EMA and FDA for Trodelvy in combination with Keytruda for patients with PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer.
Trodelvy is currently approved as a second-line or later treatment for metastatic triple-negative breast cancer and for certain patients with metastatic HR-positive/HER2-negative breast cancer.
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