In 2013, ISTODAX (romidepsin) was authorized under a Notice of Compliance with conditions (NOC/c) for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy, pending the results of trials to verify its clinical benefit. ISTODAX is now available only under Celgene Inc.’s, a Bristol-Myers Squibb company, Restricted Access Program and should not be initiated in new patients. This is based on a Phase 3 confirmatory study that failed to demonstrate ISTODAX, in combination with chemotherapy, was more effective than chemotherapy alone at delaying the progression of PTCL.
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