UPDATED: Bayer, Onyx drug Stivarga rolls on with EU approval

Stivarga, the cancer drug that Bayer developed and partners on with Onyx Pharmaceuticals ($ONXX), has nabbed yet another approval, this time in Europe, as it rolls toward its anticipated blockbuster status.

The European Commission has approved Stivarga (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer. Just 10 days ago, Japanese regulators cleared the colon cancer treatment for a new use against gastrointestinal stromal tumors. The fast-tracked drug 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, and Bayer counts it among its most promising new products. Bayer is also a partner with Onyx on the the cancer med Nexavar, which is already approved for liver and kidney cancer, and was fast-tracked this week by the FDA for treatment of thyroid cancer. Nexavar brought in €792 million last year, or about $900 million.

Of course, Bayer's partner will soon be Amgen ($AMGN), which this week nailed down its $10.4 billion deal to buy Onyx. Amgen saw the promise in Onyx' innovative cancer drugs, like Kyprolis, the multiple myeloma drug that was seen as a linchpin to the deal and one believed by analysts to have huge potential. Launched last summer, Kyprolis brought in $64 million by year's end, and by the end of the second quarter this year, it had racked up another $125 million. Analysts have forecast it to hit $2 billion to $2.4 billion in sales by 2019. That is the kind of quick growth Amgen wants to see as its biggest-selling drugs are threatened by new competition from biosimilars.

- here's the announcement

Special Report: Kyprolis - Top 20 orphan drugs by 2018

Editor's Note: The story was updated to indicate that Bayer is the developer of Stivarga but shares it with Onyx.

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