PDUFA date for tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) is deferred. BeiGene + Novartis
BeiGene announced that the 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 FDA is deferring action on the application until the inspections are complete.
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 they continue to monitor the public health situation and travel restrictions. BeiGene and Novartis will continue to work actively with the FDA to support scheduling the required inspections as soon as possible.
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