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FDA Approvals, News & UpdatesFollicular LymphomaLymphoma

FDA Approved Ukoniq, New Targeted Therapy, for Marginal-Zone and Follicular Lymphoma

Ukoniq is the first dual inhibitor of PI3K-delta and CK1-epsilon to be approved by the FDA, and is the first targeted, once-daily oral therapy option for marginal-zone or follicular lymphoma.
April 2021 Vol 7 No 2

In February 2021, the FDA approved Ukoniq (umbralisib; from TG Therapeutics), an oral kinase inhibitor, for the treatment of adults with relapsed or refractory marginal-zone lymphoma (MZL) or with relapsed or refractory follicular lymphoma. Ukoniq is used for MZL after 1 or more anti-CD20 therapies, and for follicular lymphoma after 3 or more lines of systemic therapy. Ukoniq is the first dual inhibitor of PI3K-delta and CK1-epsilon to be approved by the FDA.

The FDA approval of Ukoniq was based on results from 2 cohorts that included 69 patients with MZL and 117 patients with follicular lymphoma who have previously received several lines of therapy. All patients received oral Ukoniq once daily until disease progression or until unacceptable side effects.

The overall response rate was 49% among the patients with MZL, with 16% reaching a complete response (remission). In the patients with follicular lymphoma, the overall response rate was 43%, including 3% complete responses.

The most common side effects with Ukoniq were diarrhea/colitis, fatigue, nausea, neutropenia, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash.

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Last modified: April 28, 2021

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