Shots:

• The EMA’s CHMP has issued a positive opinion recommending approval of tislelizumab as monotx. for adult patients with unresectable, LA or metastatic ESCC after prior Pt-based CT
• The MAA was based on the P-III study (RATIONALE 302) evaluating tislelizumab (humanized IgG4 anti-PD-1 mAb) vs CT in 513 patients from 132 research sites in 11 countries in Asia, EU & North America. The study met its 1EPs & showed benefit, m-OS was 8.6 vs 6.3mos. & the safety profile was consistent with prior trials
• The MAA also incl. safety data for 1972 patients who received tislelizumab monotx. in 7 clinical trials. Additionally, regulatory submissions for tislelizumab are under review by authorities in the US, UK, Australia, China, New Zealand, Brazil, Korea, Switzerland & Indonesia

Ref: BeiGene   | Image: BeiGene

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