This site is intended for healthcare professionals
News

BeiGene announces acceptance of a sBLA in China for tislelizumab in microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors.

Read time: 1 mins
Last updated:8th Jun 2021
Published:9th Jun 2021
BeiGene, Ltd. has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for anti-PD-1 antibody tislelizumab for the treatment of patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors. The sBLA is supported by clinical results from a single-arm, multi-center, open-label, pivotal Phase II clinical trial (NCT03736889) to evaluate efficacy and safety of tislelizumab as monotherapy in patients with previously treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumors, with an enrollment of 80 patients in China. Patients received tislelizumab 200 mg intravenously every three weeks until disease progression, unacceptable toxicity, or withdrawal.
Condition: Microsatellite Instability-High (MSI-H) cancer
Type: drug
Register for free access to this exclusive healthcare learning resource


Why sign up with Medthority?

Develop your knowledge with our disease and condition focused Learning Zones

Access content from credible sources, including expert-led commentary, videos, podcasts, and webinars as well as clinical trials, treatment information and guidelines 

Personalised dashboard providing updates and recommendations for content within your areas of interest