Bayer HealthCare has obtained approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Nexavar (sorafenib) for treatment of patients with unresectable differentiated thyroid carcinoma.
Nexavar’s approval in Japan is supported by data from the multicentre, placebo-controlled Phase III DECISION (‘stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer’) study.
The international Phase III DECISION study, which randomised a total of 417 patients, met its primary endpoint of extended progression-free survival. Safety and tolerability profile of sorafenib was generally consistent with the known profile of sorafenib.
The most common treatment-emergent adverse events in the sorafenib arm were hand-foot skin reaction, diarrhea, alopecia, weight loss, fatigue, hypertension and rash.
Nexavar was awarded orphan drug status by the MHLW for thyroid carcinoma in September 2013.
Bayer HealthCare executive committee and global development head Dr Joerg Moeller said: "This is the third indication for Nexavar, which is already approved in more than 100 countries worldwide for hepatocellular carcinoma and advanced renal cell carcinoma, and we are pleased that this cornerstone treatment continues to reach cancer patients across the globe."
Co-developed by Onyx Pharmaceuticals and Bayer, Nexavar (sorafenib) is an oral multi-kinase inhibitor.
Nexavar was approved in the US in November 2013 and in the EU in May for treatment of progressive, locally advanced or metastatic differentiated thyroid cancer that is refractory to radioactive iodine.
Image: Bayer receives approval for Nexavar in Japan for treatment of differentiated thyroid cancer. Photo: courtesy of Bayer HealthCare AG.