The FDA has granted accelerated approval to the once-daily, oral, dual inhibitor of PI3K-d and CK1-epsilon, umbralisib (Ukoniq), as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least 1 prior anti-CD20 based regimen or follicular lymphoma (FL) after at least 3 prior systemic therapies, announced the drug’s developer, TG Therapeutics.1
The FDA recommended dose of umbralisib is 800 mg taken orally once daily with food until disease progression or unacceptable toxicity.
The approval was primarily based on data from the MZL and FL patient cohorts of the global, multicenter, open-label phase 2b UNITY-NHL trial (NCT02793583).2 The MZL cohort was designed to evaluate the safety and efficacy of single-agent umbralisib in patients with MZL who have received at least 1 prior anti-CD20 regimen. The FL cohort was designed to evaluate the…
