Sherman Says Lenvatinib Approval “Likely” as FDA Decision Date Nears

February 12, 2015 7:04 PM

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With a deadline of April 14, the FDA will soon make its final approval decision on the oral multikinase inhibitor lenvatinib as a treatment for patients with progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC).

The FDA is reviewing lenvatinib based on findings from the phase III SELECT trial, which were published today in The New England Journal of Medicine. SELECT randomized 392 patients with RAI-refractory DTC to lenvatinib or placebo, with lenvatinib reducing the risk of disease progression by 79% (HR =...

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