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…
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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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