2009-11-06
In collaboration with the Food and Drug
Administration (FDA), and as a service to our members, ASH provides information
about newly approved therapies for patients. This allows the agency to inform
hematologists and professionals in hematology-related fields of recent
approvals in a timely manner. Included in the message below is a link to the
product label, which provides the relevant clinical information on the
indication, contraindications, dosing, and safety. In providing this
information, ASH does not endorse any product or therapy and does not take any
position on the safety or efficacy of the product or therapy described. The
following is a message from the FDA’s Office of Oncology Drug Products.
On November 5, 2009, the U.S. Food and Drug Administration granted
approval to romidepsin for injection (ISTODAX®, Gloucester
Pharmaceuticals Inc.) for the treatment of cutaneous T-cell lymphoma (CTCL) in
patients who have received at least one prior systemic therapy.
The efficacy and safety of romidepsin were evaluated in two
single-arm, multicenter, open label trials. Efficacy was assessed in 167
patients with CTCL treated in the United States, Europe, and Australia. Study 1
included 96 patients with CTCL who had received at least one prior systemic
therapy. Study 2 included 71 patients with CTCL who received a median of two
prior systemic therapies. In both trials, patients could be treated until
disease progression. Overall response was evaluated according to a composite
endpoint that included assessments of skin involvement, lymph node and visceral
involvement, and Sézary cells.
The primary efficacy endpoint for both trials was the overall
response rate (ORR) based on the investigator assessments, and defined as the
proportion of patients with confirmed complete response (CR) or partial
response (PR). The ORRs in these two trials were similar (34 and 35 percent in Study 1
and Study 2, respectively) and CR rates were the same (6 percent). The median response
duration was 15 months in Study 1 and 11 months in Study 2.
Safety data was available and evaluated in 185 patients with CTCL.
The most common adverse reactions in Study 1 were nausea, fatigue, infections,
vomiting, and anorexia. The most common adverse reactions in Study 2 were
nausea, fatigue, anemia, thrombocytopenia, ECG T-wave changes, neutropenia, and
lymphopenia. Serious adverse reactions reported in > 2 percent of the patients in
Study 1 were infection, sepsis, and pyrexia. Serious adverse reactions reported
in > 2 percent of the patients in Study 2 were infection, supraventricular
arrhythmia, neutropenia, fatigue, edema, central line infection, ventricular
arrhythmia, nausea, pyrexia, leukopenia, and thrombocytopenia.
The recommended dose and schedule of romidepsin is 14 mg/m2
intravenously over four hours on days 1, 8, and 15 of a 28-day cycle.
Full
prescribing information, including clinical trial information, safety, dosing,
drug-drug interactions and contraindications is available.
back to top
