FDA grants Priority Review for AbbVie's venetoclax NDA

• The FDA will review AbbVie's (NYSE:ABBV) New Drug Application (NDA) for venetoclax under its Priority Review designation, shortening the review clock to six months from the standard 10 months. The marketing application seeks clearance of venetoclax for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior line of therapy, including patients with a 17p deletion.
• Breakthrough Therapy-tagged venetoclax, co-developed with Roche (OTCQX:RHHBY), is a small molecule inhibitor of the BCL-2 protein, which plays a key role in apoptosis (programmed cell death). Blocking BCL-2 is believed to restore the signaling system that tells cancer cells to self-destruct.
• AbbVie's Marketing Authorization Application (MAA) seeking clearance in the EU is currently under review by the European Medicines Agency.
• Previously: AbbVie's venetoclax successful in mid-stage study in hard-to-treat blood cancer; regulatory submissions expected before end of year (Aug. 12, 2015)
• Previously: Venetoclax a Breakthrough Therapy for blood cancer (May 7, 2015)