FDAnews Drug Daily Bulletin

FDA Committee Endorses Treatments for Breast Cancer, Sickle Cell Disease

May 31, 2017

The FDA’s Oncologic Drugs Advisory Committee recommended that the agency approve two NDAs, one in breast cancer and one in sickle cell disease.

The agency asked the committee to evaluate Puma Biotechnology’s neratinib as an extended adjuvant treatment in early-stage, HER2-overexpressed breast cancer, following at least one year of Herceptin-based therapy. The committee also examined Emmaus Medical’s L-glutamine treatment for sickle cell disease.

The Oncologic Drugs Advisory Committee voted 12 to 4 recommending neratinib for approval, despite FDA concerns over a Phase III clinical trial that underwent several adjustments and had three different sponsors.

Several committee members called on the FDA to narrow neratinib’s indication, if approved, by limiting the gap between Herceptin and neratinib treatment to one or two years. The four members voting no also cited the broad indication as a primary concern.

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