Gilead’s Trodelvy Receives the EC Approval for 1L Metastatic TNBC Patients Ineligible for PD-1/PD-L1 Inhibitor Therapy
Shots:
- The EC has approved Trodelvy monotx. as a 1L therapy for the treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy across all 30 EEA states
- Approval was backed by the P-III (ASCENT-03) trial showing a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors
- Also, the EMA has received a supplemental filing for Trodelvy + Keytruda for PD-L1+ unresectable LA/M TNBC, while Gilead also submitted another filing for Trodelvy as 1L therapy either as monotx. for pts ineligible for PD-(L)1 inhibitors or with Keytruda (IV or SC) for PD-L1+ tumors (CPS ≥10) to the FDA
Ref: Businesswire | Image: Gilead | Press Release
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