On August 4, 2020 Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, reported that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Ripretinib targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST (Press release, Zai Laboratory, AUG 4, 2020, View Source [SID1234562848]).
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"The grant of this priority review for ripretinib NDA underscores the potential of ripretinib to alter the treatment landscape for GIST patients, especially for those who are refractory to prior therapies," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "The magnitude of the unmet need for GIST patients in China is significant, with over 30,000 Chinese patients diagnosed each year. We thank the agency for their commitment and continued support to patients in need and look forward to working closely with them to advance this important therapy toward approval."
Priority review was established in China to encourage the new drug development and accelerate the market access of drugs with significant clinical value and urgent clinical need. It is implemented under the Drug Registration Rules (Bureau Order 27) and the Working Procedure for Priority Review and Approval of Drug Marketing Authorization (Tentative, NMPA 2020 No. 82) effective on July 1, 2020 and July 7, 2020, respectively. According to these guidelines, the regulatory authority will prioritize the review process and evaluation resources for applications under priority review, which should expect reduced review and approval timelines.
About Ripretinib
Ripretinib is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a unique dual mechanism of action that regulates the kinase switch pocket and activation loop. Ripretinib inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST, as well as the primary exon 17 D816V mutation involved in systemic mastocytosis, or SM. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.
Ripretinib is approved by the U.S. FDA under the brand name QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Ripretinib is also approved by Health Canada under the brand name QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration under the brand name QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Deciphera Pharmaceuticals is developing ripretinib for the treatment of KIT and/or PDGFRα-driven cancers, including GIST, SM, and other cancers.
Zai Lab has an exclusive license agreement with Deciphera for the development and commercialization of ripretinib in Greater China (Mainland China, Hong Kong, Macau and Taiwan).