Breakthrough status for Pfizer's palbociclib; Merck & Co Noxafil NDA accepted

Global pharma behemoth Pfizer (NYSE: PFE) is the latest to gain a “Breakthrough Therapy” designation by the US Food and Drug Administration, this being for the firm’s investigational compound palbociclib (PD-0332991) for the potential treatment of patients with breast cancer.

Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine if it is “intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.”  The Breakthrough Therapy designation is distinct from the FDA’s other mechanisms to expedite drug development and review.2

Will work with FDA on development program