Astellas’ Vyloy (Zolbetuximab) Plus Chemotherapy Gains the EC’s Approval for Advanced Gastric and Gastroesophageal Junction Cancer
Shots:
- The EC has granted approval to Vyloy + fluoropyrimidine & Pt-based CT as a 1L treatment of CLDN 18.2+, HER2-ve, locally advanced unresectable or metastatic G/GEJ adenocarcinoma in adults with tumors, valid across the EU plus Iceland, Liechtenstein & Norway
- The approval was based on the P-III (SPOTLIGHT & GLOW) studies assessing Vyloy + mFOLFOX6 and Vyloy + CAPOX, respectively, vs PBO as a 1L treatment of CLDN 18.2+, HER2-ve, locally advanced unresectable or metastatic G/GEJ cancer
- Studies showed improved PFS, with mPFS of 10.61mos. vs 8.67mos. (SPOTLIGHT) & 8.21mos. vs 6.80mos. (GLOW) as well as improved OS, with mOS of 18.23mos. vs 15.54mos. (SPOTLIGHT) & 14.39mos. vs 12.16mos. (GLOW)
Ref: Astellas | Image: Astellas
Related News:- Astellas Reports the CHMP’s Positive Opinion of Zolbetuximab to Treat Gastric and Gastroesophageal Junction 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.
