FDA panel: PI3K inhibitor approvals for blood cancers should be backed by randomized data

The FDA Oncologic Drugs Advisory Committee voted Thursday in favor of randomized data to support future approvals of phosphatidylinositol-3-kinase inhibitors, which are being developed for patients with hematologic malignancies.
The 16-0 vote, with one abstention, followed more than 3 hours of presentations and discussion on toxicities associated with PI3K inhibitors, trials that have shown a potential detriment in OS, limited exploration of dosing, and the limitations of single-arm trials that served as the basis for approvals of these drugs.
“This is a very different advisory committee

The FDA Oncologic Drugs Advisory Committee voted Thursday in favor of randomized data to support future approvals of phosphatidylinositol-3-kinase inhibitors, which are being developed for patients with hematologic malignancies.
The 16-0 vote, with one abstention, followed more than 3 hours of presentations and discussion on toxicities associated with PI3K inhibitors, trials that have shown a potential detriment in OS, limited exploration of dosing, and the limitations of single-arm trials that served as the basis for approvals of these drugs.
“This is a very different advisory committee