Astellas Receives Approval from the European Commission for VYLOYTM (zolbetuximab) in Combination with Chemotherapy 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)
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