FDA Accepts Neratinib NDA for HER2-Positive Breast Cancer


“The FDA has accepted a new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin), according to a statement from the developer of the TKI, Puma Biotechnology.

“The application included findings from the phase III ExteNET study, in which neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, according to findings published in Lancet Oncology. The FDA completes a standard review within 12 months from the time of submission, which was completed for neratinib on July 21, 2016.”

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