FDA APPROVES MERCK'S ZOLINZA FOR CTCL PATIENTS

Merck announced that the FDA has approved oral Zolinza (vorinostat) 400 mg once daily for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin's lymphoma, who have progressive, persistent or recurrent disease during or following two systemic therapies. CTCL is a cancer of the T-cells, a type of white blood cell, which affects the skin.

Zolinza is a histone deacetylase (HDAC) inhibitor. Based on in vitro studies, Zolinza inhibits the enzymatic activity of HDAC1, HDAC2, HDAC3 (class I) and HDAC 6 (class II) at nanomolar concentrations. In some cancer cells, excess amounts of the enzyme HDAC prevent the activation of genes that control normal cell activity. Zolinza is believed to decrease the activity of HDAC, which allows for the activation of genes that may help to slow or stop the growth of cancer cells.

The approval is based on two open-label clinical studies in which CTCL patients with refractory CTCL were evaluated to determine their response rate to oral Zolinza. One study was a Phase IIb, single-arm trial and the other assessed several dosing regimens. In both studies, patients were treated until disease progression or intolerable toxicity.

Zolinza will be made accessible to patients through Merck's Accessing Coverage Today program. Patients without insurance coverage may be eligible for Merck's patient assistance program, which allows them to receive Zolinza free of charge.