The Food and Drug Administration sent a letter to drug manufacturers encouraging them to develop medications to treat pediatric cancer.
The Food and Drug Administration sent a letter to drug manufacturers encouraging them to develop medications to treat pediatric cancer.
According to the letter, differences in the biology of adult and pediatric tumors make it difficult to apply data from adult cancer studies to the pediatric population. "It will therefore usually be impossible to rely on pharmacokinetic and safety data alone to guide use of these agents in children, and it will be necessary to evaluate the effectiveness and safety of new agents in pediatric populations," the letter stated.
To encourage the development of new treatments, the FDA is making written requests to sponsors of new drugs that may qualify for exclusivity extensions under the Food and Drug Administration Modernization Act of 1997. The requests will generally ask for early phase I studies to assess pediatric tolerability and to measure the effects of the drugs on pediatric tumors. If the results of the phase I studies are positive, further studies in specific populations will be conducted.
"To expedite this initiative we suggest that sponsors discuss a pediatric development plan with a pediatric study group to utilize their expertise and resources to optimize study design and patient accrual and to determine which cancers should be studied," the letter stated. "Sponsors are encouraged to generate proposals for written requests in conjunction with pediatric cooperative groups prior to submission of the proposal to the Division of Oncology Drug Products." PR
