EMA reviewing Puma's neratinib

Puma Biotechnology Inc. (NASDAQ:PBYI) said EMA accepted for review an MAA for oral neratinib (PB272) as an extended adjuvant treatment of HER2-positive early stage breast cancer previously treated with Herceptin trastuzumab.

Puma submitted the MAA in June. Last month, it submitted an NDA to FDA in the same indication and reported interim five-year survival data from a Phase III study of the HER1, HER2 and HER4 kinase inhibitor (see BioCentury Extra, July 22). ...