Merck's capsule Zolinza (vorinostat) for treatment of cutaneous T-cell lymphoma has been approved under six-month priority review, FDA announced, Oct. 6.

The orphan drug is a new molecular entity and the first in the class of histone deacetylase inhibitors. It is approved for treatment of refractory CTCL.

Merck submitted the Zolinza NDA based on two clinical trials with 107 patients who received the treatment after their disease had recurred following other treatments, FDA said.

One open-label study that enrolled 74 patients with advanced CTL who had failed a median of three systemic therapies had a 30% response rate with vorinostat (¹ Also see "Merck's Zolinza For T-Cell Lymphoma Has Early October User Fee Date" - Pink Sheet, 7 June, 2006.).

Vorinostat is also in Phase I in combination with 5-fluorouracil, leucovorin and oxaliplatin for colorectal cancer and with carboplatin and paclitaxel in patients with advanced solid malignancies.

In March, the oncologic Ontak (denileukin diftitox), an I.V. treatment for CTCL patients "whose malignant cells express the CD25 component of the IL-2 receptor," updated its label to include a warning on visual impairment (² Also see "Ontak Treatment Can Lead To Color Vision Loss, Company Warns" - Pink Sheet, 17 March, 2006.).

Ontak is part of the oncology franchise Eisai plans to acquire from Ligand in a deal announced Sept. 7 (³ Also see "Eisai Eyes Oncology Franchise With Acquisition Of Ligand Products" - Pink Sheet, 8 September, 2006.).

-Shirley Haley (s.haley@elsevier.com)

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