The US Food and Drug Administration (FDA) has granted priority review to the Bayer HealthCare's New Drug Application (NDA) Stivarga (regorafenib) tablets filed at the end of August 2012 to treat patients with metastatic and/or unresectable gastrointestinal stromal tumours (GIST) whose disease has progressed despite prior treatment with two kinase inhibitors. The submission was based upon data from the pivotal, global phase III GRID study.

The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the US. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all future global net sales of Stivarga in oncology.

This priority review follows the recent FDA approval of Stivarga for the treatment of patients with metastatic colorectal cancer (mCRC) who had been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

GIST is the most common form of sarcoma (a type of cancer that develops from certain tissues, like bone or muscle) involving the gastrointestinal tract. GIST may not cause any symptoms and may be found incidentally when the doctor is looking for other problems.

Stivarga is approved in the US for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression angiogenesis, oncogenesis and the tumour microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). It also inhibits various oncogenic and tumour microenvironment kinases including KIT, RET, PDGFR, and FGFR.

Bayer is committed to delivering science for a betterlife by advancing a portfolio of innovative treatments. Bayer's oncology franchise now includes two oncology products and several other compounds in various stages of clinical development.

Bayer HealthCare Pharmaceuticals Inc. is the US-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions.