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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
