Gilead Reports the US FDA's Acceptance of Trodelvy's sBLA for Priority Review to Treat Pre-Treated HR+/HER2- Metastatic Breast Cancer
- The US FDA has accepted sBLA of Trodelvy for priority review in adult patients with unresectable LA or metastatic HR+, HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer. The PDUFA date is expected on Feb 2023
- The sBLA was based on the P-III (TROPiCS-02) study evaluating Trodelvy vs CT in a ratio (1:1) in 543 patients. The trial met its 1EPs of PFS & 2EPs of OS, 34% reduction in risk of disease progression or death with m-PFS (5.5 vs 4mos.) and a 21% reduction in risk of death over TPC with m-OS (14.4 vs 11.2mos.). The safety profile was consistent with prior studies with no new safety concerns
- Trodelvy is a Trop-2 directed Ab-drug conjugate & was approved in 35+ countries with ongoing multiple regulatory reviews globally for LA or metastatic TNBC
Ref: Businesswire | Image: Gilead
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