Shots:
- The CHMP has granted positive opinion to zolbetuximab + CT, with the decision anticipated in Oct 2024 & applicable across the whole EU plus Iceland, Liechtenstein & Norway. Other worldwide regulatory applications are under review
- Opinion was supported by 2 P-III studies assessing zolbetuximab plus mFOLFOX6 [SPOTLIGHT (n=565)] & CAPOX [GLOW (n=507)] vs PBO as a 1L treatment of HER2-ve & CLDN18.2+ve G/GEJ adenocarcinoma; published in The Lancet & Nature Medicine, respectively
- In addition, Astellas & Roche partnered for the VENTANA CLDN18 (43-14A) RxDx Assay, an immunohistochemistry-based companion diagnostic test, to find patients for zolbetuximab treatment. The test’s review is underway by the notified body
Ref: Astellas | Image: Astellas | Press Release
Related News:- Novaliq’s Vevizye (Ciclosporin) gains the CHMP’s Positive Opinion to Prevent Moderate to Severe Dry Eye Disease (DED)
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