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news.Bayer HealthCare has submitted has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its regorafenib drug.
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The oral multi-kinase inhibitor regorafenib is used for the treatment of metastatic and unresectable gastrointestinal stromal tumors (GIST) in pre treated patients with advance in disease.
The application was based on its phase III GIST – Regorafenib In Progressive Disease (GRID) trial data, which reported that regorafenib plus best supportive care (BSC) significantly improved progression-free survival compared to placebo plus BSC in patients previously treated with imatinib and sunitinib.
Bayer HealthCare Pharmaceuticals vice president and US medical affairs head Pamela Cyrus said the submission of regorafenib for NDA brings the drug closer to treat patients with GIST.
"With the development of regorafenib and other oncology compounds, we remain committed to discovering and advancing cancer therapies for patients who are in need of new treatment options," Cyrus added.
FDA has also permitted Bayer to proceed with its expanded access program (EAP) to provide regorafenib to GIST patients through qualified clinical sites participating in the EAP.