Benzinga | Jul 20, 2020 07:37AM EDT

Zai Lab And Deciphera Announce China NMPA Accepts NDA Submission Of Ripretinib For Advanced Gastrointestinal Stromal Tumor

China NMPA acceptance of NDA follows recent U.S. FDA approval for the treatment of

adult patients with advanced GIST who have received prior treatment with 3 or more

kinase inhibitors, including imatinib

SHANGHAI, China and SAN FRANCISCO and WALTHAM, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB) and Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced that the China National Medical Products Administration (NMPA) has accepted its 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 was recently granted full approval by the U.S. Food and Drug Administration (FDA) for the treatment of fourth-line GIST. Ripretinib is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by theAustralian Therapeutic Goods Administrationfor the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.