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: PRNewswire | Image: Astellas | Press Release
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