BeiGene's PD-1 gets China's green light for bladder cancer

Tislelizumab, a PD-1 therapy from Chinese drug developer BeiGene, impressed regulators enough with its pivotal Phase 2 trial that the National Medical Products Administration approved it as a treatment option for patients with locally advanced or metastatic urothelial carcinoma, the most common form of bladder cancer, whose disease has progressed despite chemotherapy.

Initially approved for classical Hodgkin's lymphoma last December, urothelial carcinoma is tislelizumab's second approved indication. Not approved outside of China, the PD-1 therapy is being investigated in up to 15 clinical studies in China and globally, 11 of which have reached Phase 3.

"Patients with advanced UC have limited treatment options, so we are delighted to have tislelizumab, a new immuno-oncology treatment available to them," said Dingwei Ye, vice president of the Fudan University Shanghai Cancer Center, said in a press release.