Astellas’ Vyloy (Zolbetuximab) Secures the NMPA’s Approval as a 1L Treatment of Advanced G/GEJ Adenocarcinoma
Shots:
- The NMPA has granted approval to Vyloy + fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic HER2-, CLDN18.2+ G/GEJ adenocarcinoma
- Approval was supported by P-III (GLOW: n=145 & SPOTLIGHT: n=36) studies assessing Vyloy + CAPOX & mFOLFOX6, respectively, vs PBO among Chinese patients with this indication
- Studies depicted significantly improved PFS & OS, with mPFS of 8.21 vs 6.80mos. (GLOW) & 10.61 vs 8.67mos. (SPOTLIGHT) as well as mOS of 14.39 vs 12.16mos. (GLOW) & 18.23 vs 15.54mos. (SPOTLIGHT)
Ref: Astellas | Image: Astellas
Related News:- Astellas Reports the US FDA’s Approval of Vyloy (Zolbetuximab-clzb) to Treat Advanced G/GEJ Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
