Approval summary of nelarabine for T cell lymphoblastic leukemia and lymphoma is released

11-17-2006

Scientists outline the approval summary of nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma in a recent issue of Clinical Cancer Research.

Researchers in the United States prepared a review "to describe the clinical studies, chemistry manufacturing and controls, and clinical pharmacology and toxicology that led to U.S. Food and Drug Administration approval of nelarabine (Arranon) for the treatment of T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma."

"Two phase 2 trials, one conducted in pediatric patients and the other in adult patients, were reviewed. The i.v. dose and schedule of nelarabine in the pediatric and adult studies was 650 mg/m2/d daily for five days and 1,500 mg/m2 on days 1, 3, and 5, respectively. Treatments were repeated every 21 days. Study end points were the rates of complete response (CR) and CR with incomplete hematologic or bone marrow recovery (CR*)," said Martin H. Cohen and colleagues at the U.S. Food and Drug Administration.

"The pediatric efficacy population consisted of 39 patients who had relapsed or had been refractory to two or more induction regimens," stated Cohen and his collaborators. "CR to nelarabine treatment was observed in five (13%) patients and CR+CR* was observed in nine (23%) patients. The adult efficacy population consisted of 28 patients. CR to nelarabine treatment was observed in five (18%) patients and CR+CR* was observed in six (21%) patients. Neurologic toxicity was dose-limiting for both pediatric and adult patients."

"Other severe toxicities included laboratory abnormalities in pediatric patients and gastrointestinal and pulmonary toxicities in adults," the reviewers noted. "On October 28, 2005, the Food and Drug Administration granted accelerated approval for nelarabine for treatment of patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma after at least two prior regimens. This use is based on the induction of CRs."

The authors added, "The applicant will conduct post-marketing clinical trials to show clinical benefit (e.g., survival prolongation)."

Cohen and his coauthors published their summary in Clinical Cancer Research (Approval summary: Nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma. Clin Cancer Res, 2006;12(18):5329-5335).

For additional information, contact Martin H. Cohen, Division of Drug Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA. E-mail: martin.cohen@fda.hhs.gov.

Publisher contact information for the journal Clinical Cancer Research is: American Association for Cancer Research, 615 Chestnut Street, 17th Floor, Philadelphia, PA 19106-4404, USA.

Keywords: Rockville, Maryland, United States, Lymphoblastic Leukemia Therapy, Lymphoblastic Lymphoma Therapy, Nelarabine, Cancer Therapy, Chemotherapy, Oncology, Pharmaceutical and Drug Development, Drug Approval.

This article was prepared by Cancer Weekly editors from staff and other reports. Copyright 2006, Cancer Weekly via NewsRx.com.