The Food and Drug Administration reserves the breakthrough classification for products that have shown evidence in clinical studies of substantial improvement over existing options. It is designed to accelerate the development and review of medicines that may treat serious or life-threatening diseases.
The Umbralisib (TGR-1202) drug developed by TG Therapeutics is meant to help adults with marginal zone lymphoma (MZL) who did not respond to at least one anti-CD20 therapy.
Michael S. Weiss, executive chairman, and Chief Executive Officer stated in a press release: “We look forward to working closely with the FDA to bring Umbralisib, our novel PI3K-delta inhibitor to patients as quickly as possible. MZL patients who fail initial chemo-immunotherapy are left with limited treatment options. We believe Umbralisib can play an important role in fulfilling this unmet medical need”.
In their upcoming UNITY-NHL Phase 2b trial, 500 patients are to be assigned randomly to either of three groups: one receiving Umbralisib only; one given Umbralisib plus another CD20 antibody under development by the company, ublituximab; and a last one treating patients with Umbralisib, ublituximab, and the chemotherapy bendamustine.
“The MZL single agent Umbralisib cohort of the UNITY-NHL study is fully enrolled and we look forward to reporting top-line results from this cohort by mid-year and presenting the data at a major medical meeting in 2019,” Weiss said.
Previous studies reported that Umbralisib had a better long-term safety profile than any other equivalent treatments aimed at advanced leukemia and lymphoma patients.
Adverse effects common with other PI3K delta therapies were not frequent among patients treated with Umbralisib. Furthermore, the treatment can be safely combined with multiple agents to treat lymphoid malignancies.
Marginal zone lymphoma represents a group of slow growing Non-Hodgkin Lymphoma (NHL), accounting for about 8% of all cases. The average age at diagnosis is 60 years, and it is slightly more common in women than in men.
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