Bayer: Nexavar Approved In Japan For Treatment Of Thyroid Cancer - Quick Facts

(RTTNews) - Bayer HealthCare (BAYZF.PK, BAYRY.PK, BYR.L) announced that the Ministry of Health, Labor and Welfare in Japan has approved the oral multi-kinase inhibitor Nexavar (sorafenib) for the treatment of patients with unresectable differentiated thyroid carcinoma. Nexavar was granted orphan drug status for thyroid carcinoma in September 2013.

The approval in Japan is based on data from the Phase III DECISION trial. In the study, sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo. The median PFS was 10.8 months in patients treated with sorafenib, compared to 5.8 months in patients receiving placebo.

Nexavar (sorafenib), an oral anti-cancer therapy, is currently approved in more than 100 countries worldwide. Nexavar was approved for the treatment of progressive, locally advanced or metastatic differentiated thyroid cancer that is refractory to radioactive iodine in the U.S. in November 2013 and in May 2014 in the European Union.

Nexavar is co-developed by Onyx Pharmaceuticals, Inc. (ONXX), an Amgen (AMGN) subsidiary, 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.