Gilead Reports EMA's Validation of MAA for Trodelvy (sacituzumab govitecan-hziy) to Treat HR+/HER2- Metastatic Breast Cancer
- The EMA has validated a Type II variation MAA for Trodelvy to treat adult patients with unresectable or metastatic HR+, HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy & 2 additional systemic therapies in the metastatic setting
- The MAA was based on the P-III study (TROPiCS-02) evaluating Trodelvy vs CT (eribulin, capecitabine, gemcitabine, or vinorelbine) in a ratio (1:1) in 543 patients. The trial met its 1EPs of PFS & 2EPs of OS. The PFS data were published in the Journal of Clinical Oncology & OS data were presented at ESMO 2022
- The safety profile was consistent with prior studies with no new safety signals. The US FDA has accepted the sBLA of Trodelvy for priority review in Oct 2022 & the PDUFA date is Feb 2023
Ref: Gilead | Image: Gilead
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