Merck’s Zolinza gets priority review in US

Cutaneous T-cell-lymphoma (CTCL), a type of non-Hodgkin’s lymphoma, is a slow-growing form of cancer in which some of the body’s white blood cells known as T-lymphocytes or T-cells become malignant.

The priority review designation, intended for products that address unmet medical needs, means that the FDA has committed itself to act on the Zolinza application within six months. Merck expects FDA action on the NDA by early October 2006.

If approved, Zolinza would potentially be the first in a new class of anticancer 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).

“HDAC inhibitors like Zolinza are very exciting to the cancer community,” said Dr Stephen Friend, executive vice president, Oncology, Merck Research Laboratories. “Zolinza is one of several investigational therapies that represent an important part of the growing Merck Oncology franchise.”