U.S. FDA Defers Decision On BeiGene's Filing For Esophageal Carcinoma Due To Pending Inspection

The U.S. Food and Drug Administration (FDA) has deferred decision on the Biologics License Application (BLA) for BeiGene’s BGNE tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

The regulatory agency was unable to conduct required inspections in China due to COVID-19 related travel restrictions. As a result, deferring its action on the application until the inspections are complete.

Earlier in September 2021, The agency has accepted the BLA for tislelizumab in second line ESCC and provided a target action goal date of July 12, 2022.

The BLA was supported by data readout from the Phase 3 trial that enrolled 512 patients from Europe, U.S. and Asia and safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials.

John V. Oyler, Co-Founder, Chairman and CEO, commented : “We are working with our partner, Novartis, to facilitate the required inspections and bring tislelizumab to patients with second-line esophageal cancer in the U.S. following regulatory approval.”

The agency did not provide a new target action date as they continue to monitor the public health situation and travel restrictions.

The company along with its partner Novartis continues to work actively with the agency to support scheduling the required inspections as soon as possible.

Price Action : BeiGene Shares are trading around 4 percent higher at $176.89 on Thursday at the time of publication.