Gilead Reports EMA's Validation of MAA for Trodelvy (sacituzumab govitecan-hziy) to Treat HR+/HER2- Metastatic Breast Cancer
Shots:
- 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
Related Post:- Gilead Reports the US FDA's Acceptance of Trodelvy's sBLA for Priority Review to Treat Pre-Treated HR+/HER2- Metastatic Breast Cancer
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
