EMA validates MAA application for neratinib of HER2-positive early stage breast cancer that has previously been treated with trastuzumab .-Puma Biotechnology Inc.
Puma Biotechnology, Inc. has announced that the Marketing Authorization Application (MAA) for neratinib has been validated by the European Medicines Agency (EMA). Validation of the MAA confirms that the submission is complete and starts the EMA's formal review process. The potential indication for neratinib is for the extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with trastuzumab (Herceptin )-based adjuvant therapy. The MAA submission is based upon the ExteNET Phase III study, which reached its primary endpoint whereby neratinib demonstrated a statistically significant reduction of risk of invasive disease recurrence or death versus placebo.
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