FDA Pediatric Cancer Panel Suggests More International Research Collaboration

An FDA pediatric cancer advisory panel called for more international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials.

In a two-day meeting, members of the Oncologic Drug Advisory Committee’s pediatric subcommittee discussed potential pediatric development plans and written requests for two cancer drugs sponsored by Eli Lilly & Co.: prexasertib, a small-molecule inhibitor for head and neck cancer and small-cell lung cancer; and Lartruvo (olaratumab), a monoclonal antibody for sarcoma.

Lartruvo is currently being investigated as an addition to a combination of nab-paclitaxel and gemcitabine in a Phase Ib/II pediatric clinical trial. Lartruvo was granted accelerated approval in October for adult patients with soft tissue sarcoma. An NCI-sponsored Phase I trial of prexasertib in childhood solid tumors is currently recruiting patients.