> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Panel Reviewing PI3K Inhibitor Concerns
- URL: https://www.fdaweb.com/fda-panel-reviewing-pi3k-inhibitor-concerns/
- Published: 2022-03-09T12:00:00.000Z
- Updated: 2026-09-14T17:35:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151326

FDA is stepping up its review of phosphatidylinositol-3-kinase (PI3K) inhibitor safety concerns by convening a 4/21-22 Oncologic Drugs Advisory Committee meeting to review the issue. Recent concerns stem from a safety alert last month on a possible increased risk of death with TG Therapeutics’ PI3K inhibitor Ukoniq (umbralisib), which has accelerated approval for treating two specific lymphomas. An agency [drug safety communication](https://www.fda.gov/drugs/development-approval-process-drugs/fda-investigating-possible-increased-risk-death-lymphoma-medicine-ukoniq-umbralisib?utm%5Fmedium=email&utm%5Fsource=govdelivery) says FDA has determined that initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible increased risk of death in patients taking the drug.

“Because of the seriousness of this concern and the similarities between the two types of cancer for which this drug is approved and the type of cancer that was studied in the clinical trial,” the notice says, “we are alerting patients and healthcare professionals that we are reevaluating this risk against the benefits of Ukoniq for its approved uses.” FDA said it is continuing to evaluate the results from the UNITY trial and has suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while the findings are reviewed.

A just-posted *Federal Register* [notice](https://public-inspection.federalregister.gov/2022-05022.pdf?ref=fdaweb.com) indicates that panel members on 4/21 will discuss the “appropriate approach for phosphatidylinositol-3-kinase inhibitors currently under development in patients with hematologic malignancies and whether randomized data should be required to support a demonstration of substantial evidence of effectiveness and that the drug is safe for its intended use in the proposed population.” On 4/22, they will discuss TG Therapeutics’ supplemental NDA for Ukoniq and a BLA for ublituximab injection. The proposed indication for the two products is a combination use for treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Additionally, panel members are scheduled to discuss the existing Ukoniq accelerated approval indications in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma.