Health Canada has approved Bayer’s Nexavar (sorafenib tablets) for treatment of patients with locally advanced or metastatic, progressive, differentiated (papillary/follicular/Hurthle cell) thyroid carcinoma, refractory to radioactive iodine.
Nexavar’s approval in Canada is supported by a positive outcome from the Phase III DECISION (‘stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer’) trial.
The Phase III study has met the primary endpoint of progression-free survival. Sorafenib has significantly extended the progression-free survival when compared with placebo in this study.
The safety and tolerability profile of sorafenib in patients was generally consistent with the known profile of sorafenib in the trial.
The most common treatment-emergent adverse events in the sorafenib arm were hand-foot skin reaction, diarrhoea, alopecia, weight loss, fatigue, hypertension and a rash.
Co-developed by Onyx Pharmaceuticals and Bayer, Nexavar is an oral anti-cancer therapy that is currently approved in more than 100 countries worldwide.
Nexavar has been approved in Canada for treatment of hepatocellular carcinoma and for treating patients with advanced renal cell carcinoma who have failed or are intolerant to prior systemic therapy.
Onyx and Bayer co-promote Nexavar in the US, while Bayer has exclusive marketing rights outside of the country. The two companies share profits globally, excluding Japan.
Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of other cancers.
Image: Histopatholgical image of papillary carcinoma of the thyroid gland obtained by a total thyroidectomy. Photo: courtesy of KGH.