FDA Gives Nod to Onyx and Bayer for Stivarga in Gastrointestinal Tumors

There is some potentially very good news for those with gastrointestinal stromal tumors. The FDA has granted a priority review to the New Drug Application of Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) for Stivarga tablets to treat patients with metastatic and/or unresectable gastrointestinal stromal tumors whose disease has progressed despite prior treatment with two kinase inhibitors.

The companies submitted data from the pivotal, global Phase III GRID study and this priority review is granted to potential medicines which can offer treatment where little or no adequate therapy exists. The Prescription Drug User Fee Act will show that the FDA will aim to complete its review within six months from the receipt of the new drug application rather than in a ten-month usual review period.

So, what does this do for Onyx? Stivarga is a Bayer compound developed by Bayer. The drug is jointly promoted by Bayer and Onyx in the U.S after a 2011 where Bayer entered into an agreement where Onyx receives a royalty on all future global net sales of Stivarga in oncology. It is worth noting that today's news of being granted a priority review follows the recent FDA approval of Stivarga for the treatment of patients with metastatic colorectal cancer 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.

Onyx shares closed at $79.89 with a market cap of $5.2 billion on Friday and the 52-week range is $35.73 to $93.18. Thomson Reuters is calling for losses from Onyx this year and next year. The consensus revenue estimates are $322.8 million this year and $506.6 million next year.


Filed under: 24/7 Wall St. Wire, Healthcare Tagged: ONXX