Bayer HealthCare submit NDA for BAY 73-4506 as treatment for GIST

Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA for BAY 73-4506 (regorafenib) for the treatment of metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST) in patients whose disease has progressed despite prior treatment.

The submission is based on data from the pivotal Phase III GRID trial, which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared to placebo plus BSC in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm and there was a positive trend in the regorafenib group in improving overall survival. In addition, the study design allowed patients receiving placebo to cross-over following disease progression. Results from the study were presented at the Annual Meeting of the American Society of Clinical Oncology in June 2012.