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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%). 

References

  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. https://bit.ly/2Drz1s3?rel=0" . 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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