BeiGene’s Tislelizumab Receives the NMPA Approval for Microsatellite Instability-High or Mismatch Repair-Deficient Solid Tumors
Shots:
- 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
