BeiGene’s Tislelizumab Receives the NMPA Approval for Microsatellite Instability-High or Mismatch Repair-Deficient Solid Tumors
- The NMPA has granted conditional approval to tislelizumab for advanced unresectable or metastatic MSI-H or dMMR solid tumors including CRC who had been treated with fluoropyrimidine, oxaliplatin and irinotecan & other advanced solid tumors
- The approval was based on the P-II trial to evaluate tislelizumab (200mg, IV, q3w) as monothx. in 80 patients with previously treated LA unresectable or metastatic MSI-H or dMMR solid tumors. The 1EPs is ORR & 2EPs, including TTR, DoR, DCR & PFS, OS, safety & tolerability
- Tislelizumab is a humanized IgG4 anti-PD-1 mAb. Additionally, tislelizumab’s BLA is currently under US FDA’s review for ESCC with an anticipated PDUFA date of July 12, 2022
Ref: Businesswire | Image: BeiGene
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