FDA approves Merck anticancer treatment

Zolinza is a once daily treatment specifically for patients with cutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin's lymphoma, who have progressive, persistent or recurrent disease on or following two systemic therapies. CTCL is a cancer of the T-cells, a type of white blood cell, which affects the skin.

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. Decreasing the activity of HDAC allows for the activation of genes that may help to slow or stop the growth of cancer cells.

“With today's FDA approval of Zolinza, there is now an effective new option in the fight against cutaneous manifestations of cutaneous T-cell lymphoma, specifically in patients who have tried and failed other cancer treatment options,” said Elise Olsen, director, CTCL Clinic & Research Center at Duke University Medical Center.

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 pivotal clinical study and the other assessed several dosing regimens.

Zolinza was developed as an academic collaboration between Columbia University and the Sloan-Kettering Institute.