FDA approves Ligand's Ontak for cutaneous T cell lymphoma

Ligand has been granted fast-track approval by the US Food and DrugAdministration to market Ontak (denileukin diftitox; DAB389IL-2) for the second-line treatment of patients with persistent or recurrent cutaneous T cell lymphoma whose malignant cells express the CD25 component of the interleukin-2 receptor. The application to market Ontak was filed by Seragen, which has functioned as a division of Ligand since the two companies merged last year. The product was due for launch just after the Marketletter went to press.

CTCL is a form of non-Hodgkin's lymphoma, which manifests initially in the skin and can affect other organs. The median survival for early-stage CTCL is more than 10 years, but this declines to less than three years in late-stage patients with visceral involvement. Ontak reduced tumor burden by up to 30% in clinical trials, with some indications that symptoms such as intense itching and repeated skin infections can be alleviated. 10% of patients treated with Ontak in a Phase III trial showed a complete resolution of all evidence of the disease for a median duration of nine months.

Ligand notes that Ontak is suitable for around half the 16,000 patients with CTCL in the USA, and that the cost of therapy will range between $25,000 and $50,000 per patient, depending on the dose and the number of cycles of treatment required. The recommended regimen is three cycles of therapy, consisting of an infusion of 9mcg or 18mcg/kg/hour given on five consecutive days. While the cost of the drug may seem high, the company points out that existing drug therapies range from $5,000 to $60,000 a year, not including collateral costs. It has established a reimbursement program that will help patients seeking financial assistance for the purchase of Ontak.