FDA delays decision on BeiGene's cancer drug on China COVID curbs
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[July 14, 2022]
(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.
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People enter a building of biotechnology firm BeiGene Ltd at the
Suzhou Industrial Park in Suzhou, Jiangsu province, China November
22, 2019. Picture taken November 22, 2019. REUTERS/Stringer
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)
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