- Application submitted for manufacturing and marketing approval of ripretinib in Japan for the indication of “gastrointestinal stromal tumor that has progressed following cancer chemotherapy”
- Ripretinib has significantly prolonged the primary endpoint of progression-free survival compared to placebo in the INVICTUS study
- Already approved in the United States and Europe; recognized as a highly necessary medicine by the government review committee addressing drug loss in Japan
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) today announced that Ono submitted an application for the manufacturing and marketing approval of ripretinib (DCC-2618), developed by Deciphera Pharmaceuticals, Inc. (“Deciphera”), for the indication of “gastrointestinal stromal tumor that has progressed following cancer chemotherapy.”
This application is based on the results of the INVICTUS study, a global Phase 3 clinical study, evaluating the efficacy of ripretinib compared to placebo in patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. In this study, ripretinib significantly prolonged the primary endpoint of progression-free survival (PFS) compared to placebo.
“GIST is recognized as a rare disease worldwide, and ripretinib, developed by Deciphera, has already been approved in more than 40 countries and regions, including the United States and Europe. This application for approval of ripretinib represents a significant advancement for patients with GIST in Japan,” said Tatsuya Okamoto, Corporate Officer / Executive Director, Clinical Development of Ono. “Moving forward, we remain committed to developing and providing innovative medicines to meet the treatment needs of patients and the expectations of society.”
“The application submission brings us one step closer to providing patients in Japan with advanced GIST a potential new treatment option. We anticipate that this submission may help address the issue of delayed access to new medicines, which remains a significant challenge for patients in Japan,” said Ryota Udagawa, President and Chief Executive Officer of Deciphera. “As GIST is a rare type of tumor, the limited availability of disease information and current treatment options are likely to cause significant anxiety for patients. Together with our group companies, we will continue to make every effort to deliver ripretinib to patients in Japan suffering from advanced GIST as quickly as possible.”
