Astellas Reports the CHMP’s Positive Opinion of Zolbetuximab to Treat Gastric and Gastroesophageal Junction Cancer
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
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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.
