FDA discourages Sunesis from submitting NDA

Sunesis Pharmaceuticals Inc. (NASDAQ:SNSS) plunged $2.01 (58%) to $1.46 in after-hours trading Thursday after it said FDA "did not support" submission of an NDA for Qinprezo vosaroxin to treat acute myelogenous leukemia (AML) in patients 60 or older without additional clinical evidence. The company had met with FDA this week.

Last year, Qinprezo in combination with cytarabine missed the primary endpoint of improved overall survival (OS) in the Phase III VALOR trial (see BioCentury Extra, Oct. 6, 2014). ...