Bayer HealthCare submits NDA to FDA for GIST treatment

Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment with other kinase inhibitors.

“The submission of regorafenib for the treatment of GIST brings us one step closer to meeting a significant medical need for patients with this aggressive disease,” said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “We are committed to developing new oncology therapies for patients, especially for whom available therapies no longer work and new options are needed.”

The submission is supported by data from the Phase III GRID (GIST – Regorafenib In Progressive Disease) trial. The study evaluated regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic and/or unresectable GIST whose disease had progressed despite prior treatment with imatinib and sunitinib. Regorafenib plus BSC significantly improved progression-free survival compared to placebo plus BSC. The overall safety and tolerability profile for regorafenib in the GRID study was consistent with results from previous studies. Results from the study were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012.

Earlier this year, Bayer submitted a Marketing Authorization Application to the European Medicines Agency (EMA) and a New Drug Application to the FDA for regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC). The FDA has granted priority review status to the application for regorafenib in mCRC.