PI3K inhibitor data force FDA to re-think single-arm studies

As the cancer field moves toward broader use of single-arm studies to support accelerated approvals, FDA’s Oncology Drugs Advisory Committee has concluded that the model isn’t appropriate for all drug classes and indications.

Companies developing PI3K inhibitors for hematological malignancies should conduct randomized trials, not single-arm studies, to support approval, according to a 16-0 vote by the committee on Thursday. One voting member abstained...