August 27, 2013 | By Márcio Barra
Following the news yesterday on Amgen’s $10.4 billion Onyx buyout, Bayer AG announced today that the FDA has put its drug Nexavar, sold for liver and kidney cancer in the US in partnership with Onyx, on priority review for thyroid-cancer approval.
The priority review designation granted to Nexavar is for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer, with the submission being based on the results of the DECISION clinical trial. In this trial, a total of 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer – a type of cancer that doesn’t respond to treatment with radioactive iodine – that hadn’t receive prior therapy for thyroid cancer were randomized to receive 400 mg of oral Nexavar twice daily (207 patients) or matching placebo (210 patients). Nexavar doubled progression-free survival, to a median of 10.8 months in patients treated with it, compared with 5.8 months in control patients.
Under priority review status, the FDA aims to complete the evaluation within six months, rather than the standard review of about 10 months. The expected date for a decision is December 25, 2013.
Bayer stated that it will continue to study Nexavar in other types of cancer. Two phase III breast cancer trials are currently underway, as well as a trial of Nexavar as an adjuvant therapy in liver and kidney cancer patients.