Bayer HealthCare and partner Onyx Pharmaceuticals have submitted a new drug application to the U.S. Food and Drug Administration for Nexavar, a drug intended to treat a severe form of thyroid cancer.
The companies also have applied for marketing authorization to the European Medicines Agency, a step toward obtaining approval from European regulators.
Nexavar, which is approved for other ailments, is an oral tablet aimed at treating locally advanced or metastatic radioactive iodine refractory differentiated thyroid cancer — an advanced form of the disease.
While most forms of thyroid cancer are curable, Bayer says this stage of the disease is more difficult to treat, and is associated with a lower patient survival rate.
Bayer HealthCare, based in Wayne, said the regulatory submission is based on positive data from late-stage trials. Results from the study were presented last month at the annual meeting of the American Society of Clinical Oncology in Chicago.
Bayer and Onyx, based in San Francisco, are developing and marketing Nexavar together under collaboration co-promotion agreements.
About 35,000 people worldwide die each year of thyroid cancer, according to the World Health Organization. There are about 213,000 new cases of the disease each year.
Reporter Tom Zanki is @BizTZanki on Twitter.
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