WASHINGTON—The Food and Drug Administration’s effort to prod pharmaceutical companies into earlier testing of anticancer agents in children and teens (see FDA Tries to ‘Jump Start’ Pediatric Cancer Drug Trials) has drawn rave reviews from the pediatric oncology community.
“We have been trying to accomplish this for years, and for a variety of reasons, we could never get early access to promising agents for evaluation in children,” Gregory Reaman, MD, told ONI in an interview “We have had to wait until at least adult maximum tolerated doses have been established, but often, we do not get agents for pediatric testing until adult phase II or some early phase III studies are completed,” saud Dr. Reaman, director of the Hematology/Oncology Division, Children’s National Medical Center, and professor of pediatrics, George Washington University.
Added Victor Santana, MD, “The FDA cannot dictate to individuals which drugs they are going to develop and for whom they are going to develop them. But it is now clear that if a company is developing a drug with potential activity in pediatric disorders, the FDA wants to know about its effect in children.”
Dr. Santana is director of the Solid Tumor Service, St. Jude’s Children’s Hospital, Memphis, and a member of the FDA Oncologic Drugs Advisory Committee (ODAC).
Financial Incentives
A key problem in the past has been the lack of financial incentives for drug makers to seek pediatric indications for their products. “Developing a drug that will only impact 5,000 kids is very different from developing a drug that is going to impact 3 million adults,” Dr. Santana said.
However, he added, the FDA’s emphasis on granting a 6-month extension to drug patents or exclusive marketing rights should encourage pharmaceutical companies to speed up development of anticancer drugs for pediatric patients. “This new initiative, hopefully, will make clear that the FDA is interested in pediatric studies and, to a degree, will demand that they be done.”
Officials of the four NCI-sponsored cooperative pediatric oncology groups plan to meet shortly with representatives from 8 or 10 large drug companies to discuss ways to implement programs to meet the FDA’s goals. “We are very excited about being involved in the early strategizing about development plans for early testing in the pediatric population,” Dr. Reaman said.
