Novartis, Beigene: European Acceptance of MAA for Tislelizumab for Cancers

 BeiGene, Ltd. (NASDAQ: BGNE) today announced that marketing authorization applications (MAA) for tislelizumab, submitted by Novartis, the license holder in Europe, have been validated for regulatory review by the European Medicines Agency (EMA) for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy and for patients with non-small cell lung cancers (NSCLC) including:

• As monotherapy for the treatment of locally advanced or metastatic NSCLC after prior chemotherapy in adults,
• In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced or metastatic squamous NSCLC in adults, and
• In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations.

https://www.streetinsider.com/Corporate+News/BeiGene+%28BGNE%29+Announces+European+Acceptance+of+MAA+for+Tislelizumab+for+the+Treatment+of+Patients+with+ESCC+and+NSCLC/19880632.html