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FDA Grants Umbralisib Breakthrough Designation for Marginal Zone Lymphoma

Gina Columbus @ginacolumbusonc
Published: Tuesday, Jan 22, 2019

Michael S. Weiss

Michael S. Weiss

The FDA has granted umbralisib (TGR-1202) a breakthrough therapy designation for the treatment of adult patients with marginal zone lymphoma (MZL) who have received 1 prior anti-CD20 regimen, according to TG Therapeutics, Inc., the developer of the PI3K-delta inhibitor.

Regarding safety, the most common grade 3/4 adverse event (n = 16) was neutropenia (15%), followed thrombocytopenia (9%), diarrhea (6%), anemia (2%), and pyrexia (2%). 


  1. TG Therapeutics Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Umbralisib for the Treatment of Marginal Zone Lymphoma. TG Therapeutics. Published January 22, 2019." . Accessed January 22, 2019.
  2. Mato AR, Svoboda J, Luning Prak ET, et al. Phase I/II Study of umbralisib (TGR-1202) in combination with ublituximab (TG-1101) and pembrolizumab in patients with relapsed/refractory CLL and Richter’s Transformation. In: Proceedings from the 2018 ASH Annual Meeting; December 4-8, 2018; San Diego, CA. Abstract 297.
  3. Mato AR, Schuster SJ, Lamanna N, et al. A phase 2 study to assess the safety and efficacy of umbralisib (TGR-1202) in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K delta inhibitor therapy. In: Proceedings from the 2018 European Hematology Association Congress; June 14-17, 2018; Stockholm, Sweden. Abstract S808.

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