Bayer's Stivarga nabs new approval in newly popular Japan

Bayer's cancer drug Stivarga has racked up another approval. Japanese regulators cleared the colon cancer treatment for a new use, against gastrointestinal stromal tumors. It's just the latest victory for the fast-tracked drug, developed with U.S.-based Onyx Pharmaceuticals ($ONXX).

Stivarga, known generically as regorafenib, won FDA approval late last year and added a GIST indication in the U.S. in February. So far this year, the drug has brought in $87 million. Bayer counts it among its most promising new products, and it's widely expected to be a blockbuster.

Indeed, Stivarga is one of the reasons Amgen ($AMGN) made its $10 billion offer for Onyx in June. The smaller company spurned that initial bid but has been entertaining potential offers from Amgen and a variety of Big Pharma companies. Most recently, Onyx was said to be close to a deal with Amgen, but the talks stalled.

For Bayer, another Japanese indication for Stivarga is an additional avenue for growth in that country, which has recently generated renewed interest in Big Pharma. With European markets stagnating--and bent on cutting drug prices as much as possible--Japan looks even better by comparison.

Plus, the country has pledged to speed up new drug approvals, giving branded drugmakers more opportunity. Cases in point: Japan recently approved Novo Nordisk's ($NVO) new diabetes drug Tresiba, at about the same time that the FDA asked for more data. And Japan handed Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) clotbuster Eliquis its approval before the FDA did.

As for Stivarga in Europe, regulators there recommended the drug for approval in metastatic colorectal cancer in June, with final clearance expected by year's end.

- see the RTT News story

Special Reports: Regorafenib - Top 10 Late-Stage Cancer Drugs | Bayer - Top Pharma Companies by 2012 Revenues

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.