The US FDA has granted priority review designation to Bayer HealthCare's new drug application (NDA) filed for regorafenib to treat patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.
The submission was based upon data from the pivotal, global Phase III CORRECT study.
Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.
Bayer and Onyx Pharmaceuticals signed an agreement in 2011, under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology. Bayer and Onyx will co-promote regorafenib in the US.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-grants-priority-review-for-bayer-regorafenib-nda-280612
