Systemic Therapy Approved To Treat Cutaneous Lymphoma

Cheryl A. Thompson

BETHESDA, MD 06 November 2009—Gloucester Pharmaceuticals announced Thursday that FDA approved the marketing of romidepsin, or Istodax, for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have already received at least one systemic therapy for the disease.

The new drug, a histone deacetylase inhibitor, is administered by i.v. infusion over four hours on days 1, 8, and 15 of a 28-day cycle, the product's FDA-approved labeling (PDF) states. The starting dose should be 14 mg/m².

According to the labeling, nausea, weakness, or fatigue developed in more than half of the patients with previously treated CTCL who received romidepsin during either of the two clinical studies of the drug. Anemia, thrombocytopenia, electrocardiogram changes, neutropenia, lymphopenia, infections, anorexia, vomiting, hypocalcemia, or hyperglycemia occurred in more than half of the patients in the study that enrolled people who had already received at least two skin-directed CTCL therapies as well as those who had received at least one systemic therapy.

Gloucester said the National Cancer Institute sponsored the study that included patients who had received at least two skin-directed therapies for CTCL. The company sponsored the other study.

The labeling for romidepsin recommends managing moderate or worse adverse drug reactions by interrupting therapy and then perhaps reducing the dose to 10 mg/m². Therapy should stop altogether if severe, life-threatening, or disabling toxicities not involving the blood or hair recur after the dose has been reduced.

Romidepsin will be supplied as part of a kit containing a single-use vial with 10 mg of lyophilized drug powder and a vial of diluent, which is 80% propylene glycol and 20% dehydrated alcohol.

The labeling describes the preparation of romidepsin doses as a two-step process: (1) reconstitute the drug powder with 2 mL of diluent to produce a 5-mg/mL solution, and (2) transfer the appropriate amount of drug solution to 500 mL of 0.9% sodium chloride injection in a polyvinyl chloride, ethylene vinyl acetate, polyethylene, or glass container.

Gloucester said it expects Istodax, which is manufactured by Ben Venue Laboratories, to be commercially available in January.