EMA Validation Puts Neratinib One Step Closer to Approval for HER2+ Breast Cancer

Excerpt:

“The developer of neratinib, Puma Biotechnology, has announced the European Medicines Agency (EMA) has validated the marketing authorization application for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab (Herceptin).

“The validation confirms the completion of the submission process and starts the formal review by the Committee for Medicinal Products for Human Use (CHMP) and the subsequent final approval decision by the European Commission.

“The application was based on findings from the phase III ExteNET study, which were published in the Lancet Oncology. In this study, extended treatment with neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, representing a 33% improvement versus placebo (HR, 0.67; P = .009).”

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