Umbralisib
Umbralisib, sold under the brand name Ukoniq, is a medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). It is taken by mouth. 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. Umbralisib is a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon. Umbralisib was approved for medical use in the United States in February 2021. Medical uses. Umbralisib is indicated for adults with relapsed or refractory marginal zone lymphoma (MZL) who  have received at least one prior anti-CD20-based regimen; and adults with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Adverse effects. The prescribing information provides warnings and precautions for adverse reactions including infections, neutropenia, diarrhea and non-infectious colitis, hepatotoxicity, and severe cutaneous reactions. History. It has undergone clinical studies for chronic lymphocytic leukemia (CLL). Three year data (including follicular lymphoma and DLBCL) was announced June 2016. It is in combination trials for various leukemias and lymphomas, such as mantle cell lymphoma (MCL) and other lymphomas. Umbralisib was granted  breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for use in people with marginal zone lymphoma (MZL), a type of cancer with no specifically approved therapies. FDA approval was based on two single-arm cohorts of an open-label, multi-center, multi-cohort trial, UTX-TGR-205 (NCT02793583), in 69 participants with marginal zone lymphoma (MZL) who received at least one prior therapy, including an anti-CD20 containing regimen, and in 117 participants with follicular lymphoma (FL) after at least two prior systemic therapies. The application for umbralisib was granted priority review for the marginal zone lymphoma (MZL ) indication and orphan drug designation for the treatment of MZL and follicular lymphoma (FL).