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China's regulatory agency has granted priority review status to
BeiGene's new drug application (NDA) requesting the approval of
pamiparib, its investigational
PARP inhibitor, for the treatment of advanced
ovarian cancers. Priority review is granted in China to reduce the time to review and approve promising therapies that address urgent clinical needs. The NDA specifically covers patients with advanced
ovarian,
fallopian tube, or
primary peritoneal cancer who have been treated with two or more lines of chemotherapy and carry mutations in the
BRCA genes. The priority review status comes days after the Center for Drug Evaluation of China's
National Medical Products Administration agreed to
review the application. “Pamiparib is our third internally developed drug candidate that has been granted priority review in China, following
tislelizumab and
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July 28, 2020 at 07:00PM
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Advanced Ovarian Cancer Drug Pamiparib Given Priority Review in China - Ovarian Cancer News Today
"Review" - Google News
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