The Food and Drug Admin-i-stration has granted accelerated approval for an additional indication for romidepsin (Istodax) injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.
The drug had previously received approval for cutaneous T-cell lymphoma, also for patients who had received at least one prior systemic therapy.
A news release from the manufacturer, Celgene, notes that the indications are based on response rate and that clinical benefit such as improvement in overall survival has not been demonstrated.
The PTCL approval—based on a priority review, which are reserved for serious and life-threatening conditions that have an unmet medical need—is based on the results from two studies, a Phase II, multicenter, international, open-label, single-arm study in PTCL patients for whom at least one prior systemic therapy had failed, as reported at the most recent American Society of Hematology Annual Meeting, and a single-arm clinical study of the drug in patients with PTCL who had not responded to prior therapy.
Istodax for injection is an epigenetic histone deacetylase (HDAC) inhibitors, which catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. HDACs also deacetylate non-histone proteins, such as transcription factors. In vitro, Istodax causes the accumulation of acetylated histones, and induces cell cycle arrest and apoptosis of some cancer cell lines.
Meanwhile, a poster study at the International Conference on Malignant Lymphoma in Lugano, Switzerland, provides an early look into treatment patterns for the disease, via the COMPLETE international registry.
“These data from COMPLETE represent a first step toward increasing the understanding of peripheral T-cell lymphoma, where, although progress has been made in the treatment of this disease, there remains a high unmet need to further understand this complicated and rare group of non-Hodgkin lymphomas,” the Chair of the registry's international steering committee, Francine Foss, MD, Professor of Medicine, Hematology, at Yale Cancer Center and Smilow Cancer Hospital, said in a news release.
“Registries, such as COMPLETE, can be invaluable in providing ‘real-world’ data that ultimately increase the community's understanding of how specific patient populations are being treated as well as the outcomes of treatment—both in routine clinical practice and in clinical trials.”
COMPLETE—a prospective, longitudinal, multinational, observational study funded by Allos Therapeutics—is collecting data on how patients with PTCL are treated across practice settings and is expected to provide, for the first time, important and detailed information on PTCL disease management across various treatment regimens, including systemic therapy, stem cell transplant, and radiation therapy. The registry is enrolling patients with newly diagnosed disease.
At the time of presentation at the Lugano meeting, 59 sites had been activated and 98 patients enrolled—for which baseline and treatment records have been locked for 74 and 26 patients, respectively.
Baseline characteristics presented in the poster study show that the average patient was 58 years old, and that slightly more men were enrolled in the registry to date than women (44 men vs 30 women); that the most common PTCL subtypes are PTCL-NOS (18 of 74 patients; 24%), ALCL (13 of 74 patients; 18%), AITL (11 of 74 patients; 15%), T/NK cell lymphoma, nasal type (7 of 74 patients; 10%), and transformed mycosis fungoides (7 of 74 patients; 10%).
The most common initial treatment was found to be induction chemotherapy alone (17 of 26 patients; 65%).
© 2011 Lippincott Williams & Wilkins, Inc.