China NMPA approves new indication for tislelizumab

14 March 2022

Chinese biotech BeiGene (Nasdaq: BGNE) on Friday said that the China National Medical Products Administration (NMPA) has granted conditional approval to its anti-PD-1 antibody, tislelizumab, for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, including:

Patients with advanced colorectal cancer (CRC) who had been treated with fluoropyrimidine, oxaliplatin and irinotecan; and
Other advanced solid tumors who develop disease progression after prior treatment and have no satisfactory alternative treatment options.

“Results from the clinical trial of tislelizumab in patients with MSI-H and dMMR solid tumors demonstrated that tislelizumab’s treatment effect was consistent and durable across tumor types and endpoints. We are proud of this approval in China as it underscores our ongoing commitment to pursuing the full potential of tislelizumab and expanding its access where there is unmet medical need,” commented Dr Mark Lanasa, chief medical officer, solid tumors, at BeiGene.

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