FDA approves Ukoniq for two lymphoma indications
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The FDA granted accelerated approval to umbralisib for two types of relapsed or refractory lymphoma.
The approval applies to use of the agent for adults with marginal zone lymphoma who received at least one prior anti-CD20-based regimen, as well as adults with follicular lymphoma who received at least three prior lines of systemic therapy.
Umbralisib (Ukoniq, TG Therapeutics) is a dual inhibitor of the PI3 kinase-delta and CK1-epsilon.
The FDA based the approval on results of two single-arm cohorts of the open-label, multicenter UTX-TGR-205 trial.
The trial included 69 patients with marginal zone lymphoma who received at least one prior therapy, and 117 patients with follicular lymphoma who received at least two prior systemic therapies.
Patients received umbralisib dosed at 800 mg orally once daily. Treatment continued until disease progression or unacceptable toxicity.
Overall response rate and duration of response as assessed by an independent review committee served as key efficacy outcomes.
In the marginal zone lymphoma subgroup, researchers reported an ORR of 49% (95% CI, 37-61.6), with 16% of patients achieving complete response. Median duration of response was not reached (95% CI, 9.3-not estimable).
In the follicular lymphoma subgroup, researchers reported an ORR of 43% (95% CI, 33.6-52.2), with 3% of patients achieving complete responses. Median duration of response was 11.1 months (95% CI, 8.3-16.4).
The most common adverse events among umbralisib-treated patients included increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite and rash.
Eighteen percent of patients experienced serious adverse events, the most common of which were diarrhea-colitis and infection.
The FDA previously granted orphan drug designation to umbralisib for both indications, as well as priority review for the marginal zone lymphoma indication.
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