Gilead Sciences (GILD) said Tuesday that Trodelvy has received marketing approval from the European Commission as first-line treatment for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy.

The authorization is based on data from a phase 3 study that showed patients treated with Trodelvy achieved statistically significant progression-free survival compared with standard-of-care chemotherapy as a first-line treatment, Gilead said.

The company said it has submitted a supplemental filing to the European Medicines Agency for Trodelvy combined with Merck's (MRK) Keytruda for patients with PD-L1-positive unresectable locally advanced or metastatic triple-negative breast cancer based on the phase 3 data.

The application is currently under review, Gilead added.