Bayer HealthCare Pharmaceuticals Inc.'s experimental cancer drug regorafenib -- viewed as the "son of Nexavar" from Bayer and Onyx Pharmaceuticals Inc. -- was submitted Thursday for approval to the Food and Drug Administration, the companies said.
Bayer said the new drug application was submitted for regorafenib's treatment of metastatic or unresectable gastrointestinal stromal tumors in patients whose cancer continues despite prior treatments.
Regorafenib was developed by Bayer but was the center of a suit filed in May 2009 by South San Francisco-based Onyx (NASDAQ: ONXX). The suit claimed that Bayer was working behind Onyx's back on regorafenib, or "son of Nexavar."
Bayer and Onyx are partners on the liver and kidney cancer drug Nexavar, known scientifically as sorafenib. Regorafenib's chemical structure is similar to that of Nexavar, save for regorafenib's use of fluorine.
The companies settled the suit in October 2011. Onyx, led by CEO Tony Coles, nabbed $160 million and will receive 20 percent on global sales of regorafenib, while Bayer won the right to sell Nexavar in Japan.
Regorafenib has the potential to treat various types of tumors. In its Phase III study in gastrointestinal stromal tumors, or GIST, the drug was found to stop progression of the cancer, or progression-free survival, for a median of 4.8 months, compared to less than a month for patients who were given a placebo.
The most commonly reported side effects for patients in the trial who were given regorafenib were skin reactions on the hands and feet, hypertension, diarrhea, fatigue and inflammation in the mouth.
The FDA recently allowed Bayer to offer regorafenib as part of an expanded access program, which allows patients to use the drug outside of clinical trials.
Ron Leuty covers biotech, higher education and China for the San Francisco Business Times.
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