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# Accelerated Approval for TG Therapeutics Ukoniq
- URL: https://www.fdaweb.com/accelerated-approval-for-tg-therapeutics-ukoniq/
- Published: 2021-02-05T12:00:00.000Z
- Updated: 2026-09-14T16:45:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148608

FDA has granted TG Therapeutics accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon for treating adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen, and with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

Approval was based on two single-arm cohorts — one involving 69 patients with MZL who received at least one prior therapy, including an anti-CD20 containing regimen, and the other in 117 patients with FL after at least 2 prior systemic therapies, an [FDA release](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-umbralisib-marginal-zone-lymphoma-and-follicular-lymphoma?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. Efficacy was based on overall response rate (ORR) and duration of response (DOR). For patients with MZL, the ORR was 49% with 16% achieving a complete response, the agency says, adding that median DOR was not reached. For patients with FL, the ORR was 43%, with 3% achieving complete responses, and median DOR was 11.1 months, it says.

The prescribing information provides warnings and precautions for adverse reactions including infections, neutropenia, diarrhea and non-infectious colitis, hepatotoxicity, and severe cutaneous reactions.