Texas Children's Cancer Center, Baylor College of Medicine play key role in the next step towards approval
HOUSTON – Oncology patients received a small dosage of hope last week when Arranon® (nelarabine) Injection, a cancer-fighting drug, was recommended for accelerated approval by the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA). Arranon is targeted towards adult and pediatric patients fighting T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL), -- blood cancers that affect how the body makes blood and provides immunity from other diseases. The new drug, developed by GlaxoSmithKline (GSK), would be an option for patients whose disease has not responded to or has relapsed following at least two chemotherapy regimens.
Dr. Stacey Berg, co-director for Texas Children's Cancer Center clinical pharmacology group in Houston, led the Children's Oncology Group's (COG) phase 2 trial that played a major role in last week's recommendation for approval.
"The recommendation for accelerated approval is encouraging, particularly to pediatric oncologists," said Berg, who is an associate professor of pediatrics at Baylor College of Medicine. "There simply are not enough treatment options available for children with these particular cancers that often resist frontline therapy. If approved by the FDA, Arranon will give us the ability to offer more hope to our patients and their families."
In addition to the study in pediatric patients, a phase 2 study was conducted in adult patients by Cancer and Leukemia Group B (CALGB) in association with the Southwest Oncology Group (SWOG). Both of the adult and pediatric studies were sponsored by the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI), under a Clinical Trials Agreement between NCI and GSK.
Pediatric cancer continues to be the second leading cause of death among children, behind accidental injury. Each school day, nine children die from the disease.
Texas Children's Cancer Center, located within Texas Children's Hospital in Houston, is the largest pediatric cancer and blood disorder program in the country. The Cancer Center sees patients from 34 states and 26 countries and sees nearly 25,000 annually in its outpatient clinic. All of its physicians are faculty members at Baylor College of Medicine.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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