FDA approved romidepsin for injection (ISTODAXR) for the treatment of CTCL in patients who have received at least one prior systemic therapy

ASCO SIGN IN

Manage Email Subscriptions

Username:

Create an account

Why Be A Member?

Password:

Remember me

Forgot your username or password?

ASCO Membership Directory

The Remember Me feature is an automatic login process which creates a cookie on the hard drive of your computer containing a unique identifier which ASCO.org will utilize to remember you by, thereby avoiding the need to enter username and password upon subsequent visits to ASCO.org. DO NOT select this option if you share this computer with others since transactional, personal, or member only information will be accessible by other users.

To activate the Remember Me option, click the empty check box when signing in to the site. The Remember Me functionality is deactivated at the logout.

For additional information please review our Privacy Policy.

ASCO Home

Practice & Guidelines

Practice Management & Reimbursement

FDA Drug Alerts

FDA approved romidepsin for injection (ISTODAXR) for the treatment of 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 1 prior systemic therapy. Study 2 included 71 patients with CTCL who received a median of 2 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% in Study 1 and Study 2, respectively) and CR rates were the same (6%). 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% of the patients in Study 1 were infection, sepsis, and pyrexia. Serious adverse reactions reported in > 2% 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 4 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 on the FDA website.