TG Therapeutics receives Breakthrough Therapy Designation for lymphoma treatment Umbralisib

TG Therapeutics Inc (NASDAQ:TGTX) said Tuesday that the US Food and Drug Administration has granted Breakthrough Therapy Designation to the biotech’s umbralisib (TGR-1202) treatment for patients with marginal zone lymphoma (MZL), who have received at least one prior anti-CD20 regimen. 

There are currently no fully approved drugs for marginal zone lymphoma, which is the third most common B-cell non-Hodgkin lymphoma.

The Breakthrough Therapy Designation was based on interim data from the MZL cohort evaluating an umbralisib monotherapy in the ongoing UNITY-NHL Phase 2b registration-directed clinical trial.

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“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,” said TG Therapeutics CEO Michael S. Weiss in a statement. “We believe umbralisib can play an important role in fulfilling this unmet medical need.”

Weiss said the marginal zone lymphoma single agent umbralisib cohort of the UNITY-NHL study is “fully enrolled.”

“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,” said Weiss. 

TG Therapeutics headquartered in New York City is a biotech focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases.

Investors sent TG Therapeutics stock up 11% before the bell but the stock gave back its gains by midday, trading 2.2% lower at $4.42 amid a broader market pullback.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors