Astellas Reports the US FDA’s Approval of Vyloy (Zolbetuximab-clzb) to Treat Advanced G/GEJ Cancer
Shots:
- The US FDA has granted approval to Vyloy plus fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic CLDN 18.2+, HER2-ve G/GEJ adenocarcinoma
- Approval was based on the P-III (SPOTLIGHT & GLOW) studies assessing Vyloy + mFOLFOX6 and Vyloy + CAPOX, respectively, vs PBO as a 1L treatment of G/GEJ cancer. Astellas partnered with Roche to use Ventana CLDN18 (43-14A) RxDx Assay for identifying eligible patients
- Results showed PFS of 24.9% (mPFS: 10.61mos. vs 8.67mos.) & OS of 25% (mOS: 18.23mos. vs 15.54mos.) in SPOTLIGHT as well as PFS of 31.3% (mPFS: 8.21mos. vs 6.8mos.) & OS of 22.9% (mOS: 14.39mos. vs 12.16mos.) in GLOW
Ref: Astellas | Image: Astellas
Related News:- Astellas’ Vyloy (Zolbetuximab) Plus Chemotherapy Gains the EC’s Approval for Advanced 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.
