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 w
'"/>


29-Sep-2005

Page: 1 2
Related medicine news :

1. Conventional prognostic factors fail to explain better prostate cancer survival in most Asian men
2. Survival differences by race most apparent in advanced stages of breast cancer
3. Stomach cancer rate set to fall further 25 percent over next decade
4. MRI finds breast cancer before it becomes dangerous
5. Investigators uncover intriguing clues to why persistent acid reflux sometimes turns into cancer
6. New cause of tamoxifen resistance in breast cancer cells discovered at Lombardi
7. Pathway links inflammation, angiogenesis and breast cancer
8. Using MRI for diagnosis could help prevent breast cancer progression
9. Electric fields have potential as a cancer treatment
10. Shining light on pancreatic cancer
11. Method shows promise for early detection of pancreatic cancer