OSAKA, Japan — Ono Pharmaceutical Co., Ltd. has submitted an application in Japan for the manufacturing and marketing approval of ripretinib, a treatment for patients with advanced gastrointestinal stromal tumor that has progressed following prior chemotherapy.
The application is based on results from the Phase 3 INVICTUS study, which evaluated ripretinib against placebo in patients who had previously received at least three kinase inhibitors, including imatinib. The study showed that ripretinib significantly improved progression-free survival, the trial’s primary endpoint.
Ripretinib is already approved in more than 40 countries and regions, including the United States and Europe, and has been identified by a Japanese government review committee as a highly necessary medicine.
“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 and Executive Director of Clinical Development at Ono. “Moving forward, we remain committed to developing and providing innovative medicines to meet the treatment needs of patients and the expectations of society.”
Gastrointestinal stromal tumor is a rare cancer, and treatment options can be limited, particularly for patients whose disease has progressed after multiple lines of therapy.
“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.”
