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"The DMC recommendation represents another important milestone in the development of a potential new treatment option for patients with relapsed or refractory peripheral T-cell lymphoma, a patient population for which there are currently no approved agents," said Pablo J. Cagnoni, M.D., Senior Vice President and Chief Medical Officer of Allos. "We remain pleased with the progress of the PROPEL trial and look forward to continuing to drive our PDX product development and commercialization plans in 2008."

PROPEL (Pralatrexate in Patients with Relapsed Or Refractory PEripheral T-cell Lymphoma) is a pivotal Phase 2, international, multi-center, open-label, single-arm study that will seek to enroll a minimum of 100 evaluable patients with relapsed or refractory PTCL who have progressed after at least one prior treatment. Patients receive 30 mg/m2 of PDX once every week for six weeks followed by one week of rest per cycle of treatment. The primary efficacy endpoint of the study is objective response rate (complete and partial response). Secondary efficacy endpoints include duration of response, progression-free survival and overall survival.

Owen A. O'Connor, MD, PhD, Director, Lymphoid Development & Malignancy Program and Chief, Lymphoma Service, Columbia University, Herbert Irving Comprehensive Cancer Center, New York, is the international study chair.

In accordance with the PROPEL study design, in January 2007, the DMC completed an interim analysis of safety data based on the first 10 patients enrolled to the study who completed at least one cycle of treatment with PDX, and recommended that the trial continue per the protocol. Also in accordance with the study design, in September 2007, an interim analysis of patient response and safety data was conducted based on the first 35 patients enrolled to the study who completed at least one cycle of treatment with PDX. The results of the interim analysis of patient response data exceeded the pre-specified threshold for continuation of the trial, which required a minimum of four responses (complete or partial) out of the first 35 evaluable patients, as determined by independent oncology review. In addition, the DMC identified no major safety concerns and recommended that the trial continue per the protocol.

The PROPEL trial is being conducted under an agreement with the United States Food and Drug Administration (FDA) under its special protocol assessment (SPA) process. The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of an NDA, and provides an agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA. The FDA granted orphan drug designation to PDX for the treatment of T-cell lymphoma in July 2006 and granted fast track designation to PDX for the treatment of patients with T-cell lymphoma in September 2006. In April 2007, the Commission of the European Communities, with a favorable opinion of the Committee for Orphan Medicinal Products of the European Medicines Agency, or EMEA, granted orphan medicinal product designation to PDX for the treatment of patients with PTCL

Keywords: FDA, Hematology, Oncology, Peripheral T-Cell Lymphoma, Therapy, Treatment, U.S. Food and Drug Administration, Allos Therapeutics Inc.

This article was prepared by Medical Letter on the CDC & FDA editors from staff and other reports. Copyright 2008, Medical Letter on the CDC & FDA via NewsRx.com.