Giving children access to drug clinical trials is crucial, clofarabine approval shows

The accelerated approval of the drug clofarabine to treat relapsed or refractory pediatric acute lymphoblastic leukemia (ALL) demonstrates the importance of offering children rapid access to new treatments through clinical trials, according to investigators at St. Jude Children's Research Hospital. Refractory or relapsed ALL is a disease that resists treatment.

Clofarabine was approved for use in the treatment of pediatric patients 1 to 21 years old who have relapsed or refractory ALL that developed after at least two regimens of treatment. Researchers say it has been years since a new anti-cancer drug has received U.S. Food and Drug Administration (FDA) approval for pediatric use before approval for adult use. Most new anti-leukemic drugs were developed for use in adults and only later adapted for the treatment of children, they noted in an article on clofarabine published in the May issue of Nature Reviews/Drug Discovery.

"The addition of clofarabine to the list of drugs approved for treating pediatric ALL is especially significant because it has shown significant activity in different types of leukemias that were no longer responding to standard therapy," said Sima Jeha, MD, director of Developmental Therapeutics for Leukemia and Lymphoma at St. Jude and the lead investigator on the pediatric clofarabine trials. "The lack of overlapping toxicities with current agents warrants adding clofarabine to chemotherapy combinations with the aim of achieving even better responses."

During the past few decades, researchers have made major progress in understanding both the biology of leukemias such as ALL and how the genetic makeup of patients affects the outcome of drug therapy. Parallel with these advances, the cure rate for childhood ALL reached 80 percent. Part of this success is due to the modification of therapy for individual patients based on their risk of treatment failure. However, the most significant contribution to the higher survival

Contact: Carrie Strehlau
St. Jude Children's Research Hospital

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