BRIEF—US FDA to review tislelizumab in throat cancer

Beijing-based BeiGene has announced the US regulator has accepted its submission to market the checkpoint blocker tislelizumab for certain people with esophageal squamous cell carcinoma (ESCC).

The US FDA is set to make a decision by 12 July 2022. If approved, the therapy will be available as a second-line option, after chemotherapy.

Novartis has the right to develop and commercialize the treatment in the USA and other major markets outside of China, as part of a 2021 deal worth up to around $2 billion.

Tislelizumab is also under review for ESCC in China, where the therapy is already approved in five oncology indications.

The company outlined data from the Phase III RATIONALE 302 trial at ASCO 2021, showing significant benefit in prolonging survival for this patient population.