Beigene Says FDA Defers Action on BLA Due to Covid Travel Restrictions
July 14 2022 - 6:48AM
Dow Jones News
By Will Feuer
Oncology biotechnology company Beigene Ltd. said the U.S. Food
and Drug Administration has deferred action on the company's
Biologics License Application for its esophageal cancer treatment
due to Covid-19 travel restrictions in China.
The FDA has been unable to conduct required inspections in China
due to restrictions there, the company said. As a result, the
agency is deferring action on the application until the inspections
are complete.
The company's application for a biologics license for its
monoclonal antibody tislelizumab to be used as a second-line
treatment for patients with metastatic esophageal squamous cell
carcinoma remains under review, it said.
"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," Beigene Chairman and Chief Executive John Oyler
said.
Write to Will Feuer at Will.Feuer@wsj.com
(END) Dow Jones Newswires
July 14, 2022 06:33 ET (10:33 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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