On April 11, 2020, BeiGene announced that 百泽安 (generic name: Tislelizumab Injection), an anti-PD-1 antibody drug, had been approved by the National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic PD-L1-high expressing urothelial carcinoma (UC) who had failed platinum-containing chemotherapy, including those with disease progression within 12 months of neoadjuvant or adjuvant chemotherapy.
百泽安 first obtained NMPA approval in December 2019 for the treatment of patients with classical Hodgkin lymphoma. The UC indication in this approval is the second approved indication for 百泽安, as well as its first approved solid tumor indication. Previously, the supplementary New Drug Application (sNDA) for this new indication had been granted priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.
Basis for the Approval of 百泽安
The NMPA approval of 百泽安 was based on a single-arm, multicenter, pivotal Phase 2 clinical trial conducted in China and South Korea, enrolling patients with locally advanced or metastatic PD-L1-high expressing UC who had received prior platinum-containing chemotherapy.
Safety Data in the 百泽安 Prescribing Information
The safety profile of 百泽安 is derived from 934 patients enrolled in four monotherapy clinical trials of 百泽安, including the pivotal Phase 2 clinical trial for UC mentioned above.
The most common adverse reactions (≥10%) were rash, fatigue, and elevated alanine aminotransferase. Grade ≥3 adverse reactions occurring in at least 1% of patients included elevated gamma-glutamyl transferase, anemia, elevated aspartate aminotransferase, elevated alanine aminotransferase, non-infectious pneumonitis, severe cutaneous reactions, and hypokalemia.
Administration Route of 百泽安
百泽安 is administered via intravenous infusion, with a recommended dosage of 200 mg every 3 weeks. Treatment should be continued until disease progression or the occurrence of unacceptable toxicity.
