Puma submits neratinib MAA

Puma Biotechnology Inc. (NYSE:PBYI) submitted an MAA to EMA for oral neratinib (PB272) as an extended adjuvant treatment for HER2-positive early stage breast cancer previously treated with Herceptin trastuzumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).

The company reiterated that it expects to submit an NDA to FDA mid-year for the oral inhibitor of HER1, HER2 and HER4 kinases. On March 29, Puma said FDA had requested that it rewrite clinical sections of the application, delaying its U.S. submission. It had hoped to submit the application in 1Q16 (see BioCentury Extra, March 29). ...