() and Bayer HealthCare said Thursday that the U.S. FDA has granted priority review designation to their new drug application for regorafenib, a drug designed to treat patients with metastatic colorectal cancer.
The application was filed at the end of April. The FDA grants priority review to medicines that treat areas where little or no adequate therapy exists.
Regorafenib is a multi-kinase inhibitor for the treatment of patients with metastatic colorectal cancer, whose disease has progressed after all approved standard therapies.
The FDA will complete its review within a six month period from the receipt of the application, rather than the standard 10-month review cycle.
The submission was based on data from Bayer?s global phase III CORRECT study of regorafenib in combination with supportive care, that was conducted in North America, Europe, Israel, China, Japan and Australia.
In October of last year, Bayer announced that the phase III study met its main goal, with results of improved overall survival and progression-free survival.
In 2011, Bayer struck a development deal with Onyx, under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.
Both parties will co-promote the drug in the United States.
"We welcome the priority review of regorafenib by the FDA as it supports our efforts to make regorafenib available as early as possible to patients who have exhausted available therapies and urgently need new options," said Bayer?s head of global development and member of the executive committee, Dr. Kemal Malik.
The investigational drug is also currently being investigated in clinical trials for its potential to treat patients with various tumour types.
Bayer HealthCare is a healthcare and medical products company. Regorafenib is one of many cancer compounds in the company's development pipeline.
San Francisco-based Onyx is a global biopharmaceutical company focused on the development and commercialization of therapies for cancer.
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