Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved German pharma major Bayer’s (BAYN: DE) oral multi-kinase inhibitor Nexavar (sorafenib) for the treatment of patients with unresectable differentiated thyroid carcinoma. The MHLW granted Nexavar orphan drug status for thyroid carcinoma in September 2013.

“The approval of Nexavar in Japan for the treatment of unresectable differentiated thyroid carcinoma fills a significant unmet need for patients who previously lacked therapeutic options for this type of thyroid cancer,” said Joerg Moeller, a member of the Bayer HealthCare executive committee and head of global development. “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,” Dr Moeller noted.

Nexavar was approved for the treatment of progressive, locally advanced or metastatic differentiated thyroid cancer that is refractory to radioactive iodine in the USA in November 2013 and in May 2014 in the European Union.

Approval backed by Ph III DECISION trial

The approval in Japan is based on data from the Phase III DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial. In the study, sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo (HR=0.59 [95% CI, 0.46-0.76]; p<0.001), which represents a 41% reduction in the risk of disease progression or death for patients who received sorafenib compared to placebo-treated patients. The median PFS was 10.8 months in patients treated with sorafenib, compared to 5.8 months in patients receiving placebo.

The safety and tolerability profile of sorafenib in patients in the trial 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.