FDA Advisory Committee to Review Puma’s Request for Neratinib Approval

FDA Advisory Committee to Review Puma’s Request for Neratinib Approval
A U.S. Food and Drug Administration advisory committee will begin a review on May 24 of Puma Biotechnology's neratinib as a breast cancer treatment. If the independent Oncologic Drug Advisory Committee recommends approval, the FDA itself will begin reviewing the therapy. The regulator accepted Puma's New Drug Application for neratinib in September 2016. The application asked the FDA to approve the drug for early-stage HER2-positive breast cancer patients who were treated previously with a regimen that included Herceptin (trastuzumab). Puma submitted the application after findings in the Phase 3 ExteNET trial (NCT00878709) and the Phase 2 CONTROL trial (NCT02400476) proved promising. The trials tested neratinib as an extended adjuvant -- or post-surgery -- treatment for patients with early-stage, HER2-positive breast cancer. ExteNET was a double-blind, placebo-controlled trial designed to assess the safety and effectiveness of neratinib versus a placebo after adjuvant Herceptin therapy. It covered 2,840 patients in 41 countries who had surgery followed by Herceptin. Patients were randomized to receive either neratinib or a placebo for a year. After the treatment, researchers followed patients for two years to see whether they were still alive, their cancer had recurred, or they had developed a form of breast cancer called ductal carcinoma in situ that can become aggressive later. The  primary goal of the study was to see if neratinib led to disease-free survival. Neratinib reduced by 33 percent the number of patients who died or had their cance
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