Friday, 9 Dec 2022

FDA Delays Decision on BeiGene’s Cancer Drug on China COVID Curbs

(Reuters) -China-based drug developer BeiGene said on Thursday the U.S. Food and Drug Administration (FDA) has delayed a decision on its cancer drug as COVID-19 curbs in the country prevented the regulator from conducting inspections.

The FDA was expected to decide on the drug, tislelizumab, by July 12 but has now delayed its move until the inspections are complete, the company said.

The delay makes BeiGene the latest China-based company for which the FDA has cited pandemic travel restrictions as an issue following similar problems with Hutchmed Ltd, as well as U.S.-based Coherus BioSciences Inc and its Chinese partner Shanghai Junshi Biosciences Co Ltd.

BeiGene is working with its partner Novartis to facilitate the inspections to get an approval for the treatment, said Chairman and Chief Executive John Oyler.

The company’s application for tislelizumab for second-line treatment of patients with esophageal cancer includes data from a late-stage trial of 512 patients in Europe, the United States and Asia, the company said.

(Reporting by Leroy Leo in Bengaluru; Editing by Aditya Soni)

Source: Read Full Article