Posted by Michael Wonder on 09 Jun 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in microsatellite instability-high or mismatch repair-deficient solid tumours
7 June 2021 -BeiGene today announced that the Center for Drug Evaluation of the China NMPA has accepted a supplemental biologics license application for anti-PD-1 antibody tislelizumab for the treatment of patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumours.
The is supported by clinical results from a single-arm, multi-center, open-label, pivotal Phase 2 clinical trial to evaluate efficacy and safety of tislelizumab as monotherapy in patients with previously treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumours, with an enrolment of 80 patients in China.
