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Positive CHMP opinion for BeiGene’s tislelizumab to treat ESCC

Jul 21, 2023

BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval for its tislelizumab product, co-developed with Novartis.  It is seeking approval for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy.

In 2021, BeiGene and Novartis announced a collaboration agreement to jointly develop tislelizumab in the US, Canada, Mexico, member countries of the European Union, the UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. Novartis is responsible for regulatory submission and has the right to commercialise in these licensed countries following regulatory approval.

On 10 July 2023, BeiGene and Novartis ended their option for collaboration and licence agreement to commercialise ociperlimab. Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications for tislelizumab.