Pediatric Cancer Panel Recommends Moving Away from Single-Agent Studies

An FDA pediatric cancer advisory panel called on multiple sponsors to continue refining their cancer drugs to adapt them for safe and effective use in pediatric populations.

In developing future clinical trials, sponsors should consider whether the drug will be intended for use as a single agent or as part of a combination therapy, said members of the Oncologic Drug Advisory Committee’s pediatric subcommittee, in the first day of a two-day meeting.

The subcommittee heard presentations on PharmaMar’s lurbinectedin, for Ewing sarcoma and neuroblastoma, and Astellas Pharma’s gilteritinib treatment for acute myeloid leukemia, both currently under review. The subcommittee did not take votes on whether or not to recommend the applications for approval.

In future trials, the subcommittee “highly recommended” standardized doses administered to the spine and long-term toxicity monitoring, as well as guidelines for cardiac assessment and observation. — Zack Budryk