FDA Approves Nexavar For Treatment Of A Type Of Thyroid Cancer

(RTTNews) - Bayer HealthCare and Onyx Pharmaceuticals, Inc., an Amgen Inc. (AMGN) subsidiary, said Friday that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for the oral multi-kinase inhibitor Nexavar tablets for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

Nexavar was approved following a priority review by the FDA, a designation reserved for drugs that may offer a significant improvement in treatment over existing options.

The FDA approval is based on the results of the DECISION trial, an international, multicenter, placebo-controlled study.

Nexavar is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

Nexavar is currently approved in more than 100 countries. The drug is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.

Nexavar is co-developed by Onyx and Bayer, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the U.S. Outside of the U.S. Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally, excluding Japan.