umbralisib (Ukoniq)
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Indications
- relapsed or refractory marginal zone lymphoma with at least one prior anti-CD20-based regimen;
- relapsed or refractory follicular lymphoma >= 3 prior lines of systemic therapy
* FDA has withdrawn approval for Ukoniq (umbralisib) due to safety concerns[2]
- increased risk of death[2]
* manufacturer, TG Therapeutics announced it ws voluntarily withdrawing Ukoniq from the market
Dosage
200 mg tablets
Adverse effects
- common >15%
- increased serum creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, serum transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, anroxia, rash
- serious (18%)
- most often from diarrhea-colitis & infection
Mechanism of action
- inhibits PI3K-delta & casein kinase CK1-epsilon
More general terms
References
- ↑ FDA Drug Approval. Feb 5, 2021 FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-umbralisib-marginal-zone-lymphoma-and-follicular-lymphoma
- ↑ 2.0 2.1 2.2 Stern V FDA Withdraws Lymphoma Drug Approval After Investigation. Medscape. June 1, 2022 https://www.medscape.com/viewarticle/974875
FDA Drug Safety Communication. 2022. June 1. FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns. Possible increased risk of death outweighs the benefits. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approval-lymphoma-medicine-ukoniq-umbralisib-withdrawn-due-safety-concerns