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Astellas Receives Approval from the European Commission for VYLOYTM (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

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Astellas Receives Approval from the European Commission for VYLOYTM (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

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)

Ref: Astellas | Image: Astellas

Related News:- Astellas Reports the US FDA Listing of DIGITIVA to Manage Heart Failure

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