Early FDA approval for Bayer's Stivarga in advanced colorectal cancer

The US Food and Drug Administration yesterday approved German drug major Bayer’s (BAYN: DE) Stivarga (regorafenib) to treat patients with metastatic colorectal cancer, under a fast-track review process for the product.

Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA’s priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists. Stivarga is being approved one month ahead of the product’s prescription drug user fee goal date of October 27, 2012, the date the agency was scheduled to complete review of the drug application.

Bayer said Stivarga will be ready for distribution as soon as today (September 28 and set a wholesale price for the drug of $9,350 for a 28-day cycle of treatment, according to Reuters. The company is currently awaiting a colon cancer approval decision for the drug in the European Union, as well as seeking US approval of regorafenib as a treatment for gastrointestinal stromal tumors.