Bayer HealthCare seeks thyroid cancer approval for Nexavar

Bayer HealthCare and Onyx Pharmaceuticals have submitted their drug Nexavar (sorafenib) for marketing authorisation in Europe and the US as a treatment for thyroid cancer.

The companies are seeking approval of the oral multi-kinase inhibitor as a therapy for locally advanced or metastatic differentiated thyroid cancer refractory to radioactive iodine.

Data from the phase III Decision trial showed that the drug significantly extended progression-free survival compared to placebo, thus meeting the primary efficacy endpoint of the study.

There is a significant medical need for new treatments for patients whose disease has advanced and who currently have very few options available to them.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "We are committed to fully exploring sorafenib's applicability across tumour types, especially in hard-to-treat cancers where there are limited treatment options."

This comes after the company recently received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for approval of its drug regorafenib as a treatment for metastatic colorectal cancer.