FDA Delays Decision on Lenvatinib for HCC

May 25, 2018 – The FDA has extended the review period for lenvatinib as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC), to allow ample time to review the application, according to Eisai and Merck, the companies codeveloping the drug. The new action date for the supplemental new drug application (sNDA) is August 24, 2018. The sNDA submitted for lenvatinib was based on data from the phase III REFLECT trial, which were published in … (leggi tutto)