BLA for PD-1 Inhibitor tislelizumab in 2L ESCC delayed by FDA
Sino-American biotech firm BeiGene (Nasdaq: BGNE) today announced that the US Food and Drug Administration (FDA) has deferred action on the Biologics License Application (BLA) for tislelizumab as a second-line (2L) treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
The FDA has been unable to conduct required inspections in China due to COVID-19 related travel restrictions. As a result, the agency is deferring action on the application until the inspections are complete. Despite news of the delay, BeiGene’s shares were trading up nearly 4% at $176.12 mid-morning in New York.
In the letter, the FDA cited only travel restrictions and the inability to complete inspections as the reason for the deferral. The application remains under review, and the FDA did not provide a new anticipated action date as it continues to monitor the public health situation and travel restrictions.
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