NEW YORK -- September 25, 2009 -- The US Food and Drug Administration (FDA) has granted accelerated approval for pralatrexate injection (Folotyn) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
The indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated.
"Individuals with peripheral T-cell lymphoma have a very poor prognosis and almost always relapse or become refractory to initial therapy," said principal investigator Owen A. O'Connor, MD, Clinical Research and Cancer Treatment, NYU Cancer Institute, and Division of Hematologic Malignancies and Medical Oncology, NYU Langone Medical Center, New York, New York.
"As a result, there is an urgent need for new therapies to treat patients with this challenging disease. [Pralatrexate injection] has demonstrated its efficacy and safety in the PROPEL (Pralatrexate in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma) clinical trial, and I believe it will be a welcome addition for physicians who treat patients with relapsed or refractory PTCL."
In connection with the accelerated approval, Allos has agreed to undertake additional clinical studies to further verify and describe the clinical benefit of Pralatrexate injection in patients with T-cell lymphoma.
The approval was based on the results from PROPEL, an open-label, single-arm, multicentre, international study that enrolled 115 patients with relapsed or refractory PTCL, 109 of whom were considered evaluable for efficacy according to the trial protocol. Patients were considered evaluable if they received at least 1 dose of pralatrexate, their diagnosis of PTCL was confirmed by independent pathology review, and they had relapsed or refractory disease after at least 1 prior treatment.
Patients were treated with pralatrexate injection at 30 mg/m2 once weekly by intravenous push over 3 to 5 minutes for 6 weeks in 7-week cycles until disease progression or unacceptable toxicity. In addition, patients received 1mg of vitamin B12 intramuscularly every 8 to 10 weeks and 1.0 to 1.25 mg of folic acid orally on a daily basis.
The primary efficacy endpoint was overall response rate as assessed by International Workshop Criteria (IWC). The key secondary efficacy endpoint was duration of response. Response assessments were scheduled at the end of cycle 1 and then every other cycle (every 14 weeks). Duration of response was measured from the first day of documented response to disease progression or death. Response and disease progression were evaluated by independent central review using the IWC.
The results of the trial demonstrated that 29 of 109 evaluable patients, or 27%, responded to pralatrexate. The median duration of response was 287 days, or 9.4 months (range 1-503 days). Thirteen of 109 evaluable patients had a duration of response greater-than or equal to 14 weeks (range 98-503 days).
The most common grade 3/4 adverse events were thrombocytopenia, which was observed in 33% of patients; mucositis in 21% of patients; neutropenia in 20% of patients; and anaemia in 17% of patients.
SOURCE: Allos Therapeutics, Inc.
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