BRIEF—BeiGene's tislelizumab accepted for review in China

Chinese biotech firm BeiGene today announced that the China National Medical Products Administration (NMPA, formerly known as CFDA or CDA) has accepted the new drug application (NDA) for tislelizumab, an investigational anti-PD-1 antibody, as a potential treatment for patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL).

“The acceptance of our first NDA for tislelizumab represents an important milestone for BeiGene and for Chinese patients with Hodgkin’s lymphoma. Patients who relapse or don’t respond to standard treatment with chemotherapy or radiation often have poor prognoses. We are encouraged by the potential for tislelizumab to provide a new treatment option for these patients,” said Dr Jane Huang, chief medical officer, hematology, at BeiGene.

The NDA is supported by a clinical and non-clinical data package, including the results from a pivotal Phase II study of tislelizumab in Chinese patients with R/R cHL. A recent independent review of data from all 70 enrolled patients in an intent-to-treat analysis showed that with a minimum of 24 weeks of follow-up and a median follow-up time of 7.85 months at the data cut-off, overall response rate (ORR) was 85.7%, including 61.4% complete response (CR).

Last month, BeiGene also started a trial that could signal the suitability of tislelizumab – in combination with chemotherapy for non-squamous non-small cell lung cancer (NSCLC).