20 July 2020 - 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.

Zai Lab and Deciphera Pharmaceuticals today announced that the China National Medical Products Administration has accepted its new drug application for ripretinib for the treatment of adult patients with advanced gastro-intestinal stromal tumour (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. 

Ripretinib was recently granted full approval by the U.S. 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 the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Read Deciphera Pharmaceuticals press release