Oncologic Panel Meeting to Review Ukoniq sNDA

Federal Register notice: FDA has announced a 4/21-22 Oncologic Drugs Advisory Committee meeting. On 4/21, the panel will discuss the appropriate approach for phosphatidylinositol-3-kinase inhibitors currently under development for use in patients with hematologic malignancies and whether randomized data should be required to support a demonstration of substantial evidence of effectiveness. On 4/22, the committee will discuss a TG Therapeutics supplemental NDA for Ukoniq (umbralisib) tablets, and its BLA for ublituximab injection — both submitted for combination use in treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. In addition, it will discuss the existing umbralisib accelerated approval indications in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma. To view the notice, click here.