Ukoniq FDA Approval History
Last updated by Judith Stewart, BPharm on June 2, 2022.
FDA Approved: Yes (Discontinued) (First approved February 5, 2021)
Brand name: Ukoniq
Generic name: umbralisib
Dosage form: Tablets
Company: TG Therapeutics, Inc.
Treatment for: Marginal Zone Lymphoma, Follicular Lymphoma
Ukoniq (umbralisib) is a dual inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon for the treatment of marginal zone lymphoma (MZL) and follicular Lymphoma (FL).
- On June 1, 2022, the U.S. Food and Drug Administration (FDA) announced the withdrawal of the approval for Ukoniq (umbralisib) due to safety concerns.
- Updated findings from the UNITY-CLL clinical trial had continued to show a possible increased risk of death in patients receiving Ukoniq.
- It was determined that the risks of treatment with Ukoniq outweigh the benefits.
- As a result, TG Therapeutics announced the voluntarily withdrawal of Ukoniq from the market for the approved uses in MZL and FL.
- Ukoniq is indicated for the treatment of adults with:
- Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen.
- Relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
These indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Ukoniq tablets are taken once daily with food.
- Ukoniq may cause serious side effects including infections, neutropenia, diarrhea or non-infectious colitis, hepatotoxicity, severe cutaneous reactions, allergic reactions (due to the inactive ingredient tartrazine), and embryo-fetal toxicity.
- Common adverse reactions include increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash.
Development timeline for Ukoniq
| Date | Article |
|---|
| Apr 15, 2022 | TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SLL |
| Feb 5, 2021 | Approval FDA Approves Ukoniq (umbralisib) for Marginal Zone Lymphoma and Follicular Lymphoma |
| Dec 1, 2020 | TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia |
| Aug 13, 2020 | TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma |
| May 5, 2020 | TG Therapeutics Announces Positive Topline Results from the UNITY-CLL Phase 3 Study Evaluating the Combination of Umbralisib and Ublituximab (U2) for the Treatment of Patients with Chronic Lymphocytic Leukemia |
| Mar 5, 2020 | TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Follicular Lymphoma |
| Jan 16, 2020 | TG Therapeutics Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma |
| Oct 28, 2019 | TG Therapeutics Announces Positive Results from the UNITY-NHL Phase 2b Pivotal Trial Evaluating Umbralisib Monotherapy in Patients with Relapsed/Refractory Follicular Lymphoma |
| Jun 11, 2019 | TG Therapeutics Confirms Registration Path for Umbralisib in Marginal Zone Lymphoma Following FDA Meeting |
| Apr 15, 2019 | TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Marginal Zone Lymphoma |
| Jun 14, 2017 | TG Therapeutics, Inc. Announces Follow-Up Data for Combination of TGR-1202 (umbralisib) plus Ibrutinib in Patients with Relapsed or Refractory CLL and MCL at the 14th International Conference on Malignant Lymphoma |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
