Astellas Reports the Health Canada’s Approval of Vyloy (Zolbetuximab) Plus Chemotherapy for Advanced G/GEJ Cancer
Shots:
- The Health Canada has approved Vyloy + fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic CLDN 18.2+/HER2-ve G/GEJ adenocarcinoma, with further submissions under review. In addition, Canada’s Drug Agency (CDA-AMC) recommended reimbursement of Vyloy with conditions
- Approval was based on the P-III (SPOTLIGHT: n= 565 & GLOW: n= 507) studies assessing Vyloy + mFOLFOX6 & CAPOX, respectively, vs PBO as a 1L treatment of locally advanced HER2-/CLDN18.2+ G/GEJ cancer
- 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’ Vyloy (Zolbetuximab) Secures the NMPA’s Approval as a 1L Treatment of Advanced G/GEJ Adenocarcinoma
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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.
