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# FDA Defers Action on BeiGene BLA
- URL: https://www.fdaweb.com/fda-defers-action-on-beigene-bla/
- Published: 2022-07-14T12:00:00.000Z
- Updated: 2026-09-14T17:51:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152281

Citing its inability to conduct inspections in China due to Covid-19 travel restrictions, FDA has deferred action on a BeiGene BLA for tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma. The company [says](https://www.businesswire.com/news/home/20220714005202/en/BeiGene-Provides-Regulatory-Update-on-the-U.S.-Biologics-License-Application-BLA-for-PD-1-Inhibitor-Tislelizumab-in-2L-ESCC?ref=fdaweb.com) it was informed that FDA is delaying action until the inspections are complete. “In the letter, FDA cited only travel restrictions and the inability to complete inspections as the reason for the deferral,” BeiGene says. “The application remains under review and FDA did not provide a new anticipated action date…. BeiGene and Novartis will continue to work actively with FDA to support scheduling the required inspections as soon as possible.”