WASHINGTONThe Food and Drug Administrations 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, Childrens 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. Judes
Childrens Hospital, Memphis, and a member of the FDA Oncologic
Drugs Advisory Committee (ODAC).
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 FDAs 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
FDAs 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.