Puma Biotech's neratinib MAA validated in Europe

23 August 2016

USA-based Puma Biotechnology (NYSE: PBYI) says that its 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 on 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.

Puma filed for European approval of neratinib in June this year and submitted a New Drug Application to the US Food and Drug Administration in July.

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