Umbralisib approved for the treatment of select patients with relapsed/refractory marginal zone lymphoma and relapsed/refractory follicular lymphoma.



The agent is specifically indicated for adult patients with relapsed/refractory MZL who have previously received at least 1 anti-CD20–based regimens.



it is also approved for use in adult patients with relapsed/refractory follicular lymphoma who have previously received at least 3 lines of systemic treatment.


Umbralisib approval was primarily based on data from the marginal zone lymphoma and follicular lymphoma patient cohorts of the phase 2b UNITY-NHL trial.


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.


It is a once-daily, oral, dual inhibitor of PI3K-d and CK1-epsilon.


Trade name Ukoniq.



Participants received umbralisib at a once-daily dose of 800 mg until progressive disease or intolerable toxicity.



Results showed that the agent elicited an overall response rates of 49% and 16% experienced complete responses. 



The median duration of response had not yet been reached.



For patients with follicular lymphoma, the overall response rates was 43% with 3% achieving complete responses. 



Median DOR was 11.1 months.

Adverse events observed in at least 15% of patients: increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash. 

Serious AEs occurred in 18% of patients, most often from diarrhea-colitis and infection. 

The most common reasons for dose modifications were diarrhea-colitis and transaminase elevation.




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