Bayer's Stivarga races to FDA approval on the heels of Zaltrap

The earlier than expected US Food and Drug Administration approval of German drug major Bayer’s (BAYN: DE) Stivarga (regorafenib) last month (The Pharma Letter September 28), provides a new treatment for patients with metastatic colorectal cancer (mCRC) who have exhausted all other options, note analysts at industry expert GlobalData.

Stivarga was approved on September 27 - exactly one month to the day ahead of the PDUFA date - following evaluation under the FDA Priority Review program, which expedites the approval process for indications without adequate treatments. Stivarga is the second drug approved by the FDA for the treatment of mCRC in the past two months, following the approval of France’s Sanofi (Euronext: SAN) and Regeneron’s (Nasdaq: REGN) Zaltrap (ziv-aflibercept) as a second-line therapy in August (TPL August 6).

According to the World Health Organization, colorectal cancer is the fourth most common cause of cancer mortality in the world. The disease afflicts over 140,000 people annually and causes more than 51,000 deaths each year in the USA alone, according to the National Institutes of Health.