Fierce Pharma March 15, 2024
Twenty months after the FDA’s original target decision date on cancer drug tislelizumab, BeiGene has finally received the U.S. go-ahead.
The PD-1 inhibitor now carries the brand name Tevimbra. It’s approved to treat advanced esophageal squamous cell carcinoma after prior systemic chemotherapy, BeiGene said Thursday. Patients won’t be eligible for the drug if they have previously received a PD-1/L1 inhibitor.
The FDA was originally scheduled to deliver a verdict on the drug in July 2022, but COVID-related travel restrictions disrupted that plan because the agency wasn’t able to perform preapproval inspections in China. Tevimbra secured its initial approval in China in December 2019 for previously treated classical Hodgkin lymphoma.
Tevimbra isn’t the first PD-1 drug to reach esophageal cancer. Merck...
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