FDA reviewing Puma's neratinib

Puma Biotechnology Inc. (NYSE:PBYI) gained $6.21 (11%) to $65.16 on Tuesday after it said FDA accepted an NDA for oral neratinib (PB272) to treat patients with early stage HER2-amplified breast cancer previously treated with Herceptin trastuzumab. Puma said the PDUFA date for the candidate is July 21, 2017.

Puma's application includes data from the Phase III ExteNET trial, in which neratinib met the primary endpoint of extending disease-free survival (DFS) at two years vs. placebo. In an updated analysis announced in July, Puma said five-year invasive DFS rates were 90.4% for neratinib and 87.9% for placebo (HR=0.74, p=0.017) (see BioCentury Extra, July 22). ...