Merck’s Zolinza Gets Priority Review

Merck’s NDA for Zolinza for the treatment of advanced cutaneous T-cell-lymphoma (CTCL) has been granted priority review by the FDA. A priority review designation is intended for products that address unmet medical needs. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s goal is to review and act on NDAs designated as priority review within six months of receipt. Merck expects FDA action on the NDA by early October of this year.

If approved, Zolinza would potentially be the first in a new class of anti-cancer therapies called histone deacetylase (HDAC) inhibitors. Histone deacetylation is thought to be a mechanism for silencing some tumor suppressor genes and other genes responsible for cell cycle progression, cell proliferation, programmed cell death (apoptosis), and differentiation (transformation of young cells into specialized cells).