Umbralisib, sold under the brand name Ukoniq, is an anti-cancer medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL).[2] It is taken by mouth.[2]
Umbralisib is a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon.[2][4][5]
The most common side effects 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.[2]
Umbralisib was granted accelerated approval for medical use in the United States in February 2021.[2][6][7] However, due to concerns for increased long term side effects leading to inferior overall survival which led to increased FDA scrutiny in the form of an ODAC review,[8] it has been withdrawn from the US market.[9]
^ abcde"Ukoniq- umbralisib tablet, film coated". DailyMed. Archived from the original on 14 September 2021. Retrieved 13 September 2021.
^ abcdefCite error: The named reference FDA Ukoniq was invoked but never defined (see the help page).
^Cite error: The named reference FDA Ukoniq 20220601 was invoked but never defined (see the help page).
^Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, et al. (November 2019). "Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia". Blood. 134 (21): 1811–20. doi:10.1182/blood.2019002118. PMC 7042665. PMID 31558467.
^Burris HA, Flinn IW, Patel MR, Fenske TS, Deng C, Brander DM, et al. (April 2018). "Umbralisib, a novel PI3Kδ and casein kinase-1ε inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study". Lancet Oncology. 19 (4): 486–96. doi:10.1016/S1470-2045(18)30082-2. PMID 29475723.
^"TG Therapeutics Announces FDA Accelerated Approval of Ukoniq (umbralisib)" (Press release). TG Therapeutics. 5 February 2021. Archived from the original on 5 February 2021. Retrieved 5 February 2021 – via GlobeNewswire.
^"Drug Approval Package: Ukoniq (umbralisib)". U.S. Food and Drug Administration (FDA). 5 March 2020. Archived from the original on 14 September 2021. Retrieved 13 September 2021.
^"FDA Briefing Document - Phosphatidylinositol 3-Kinase (PI3K) Inhibitors in Hematologic Malignancies". Food and Drug Administration. Archived from the original on 2022-04-19. Retrieved 2022-05-30.
^"TG Therapeutics, Inc.; Withdrawal of Approval of New Drug Application for UKONIQ (Umbralisib Tosylate) Tablets, Equivalent to 200 Milligrams Base". 31 May 2022. Archived from the original on 28 May 2022. Retrieved 30 May 2022.
Umbralisib, sold under the brand name Ukoniq, is an anti-cancer medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL)...
other PI3K inhibitor for follicular lymphoma: duvelisib in December 2021, umbralisib in January 2022, and copanlisib in November 2023. These withdrawals are...
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