TG Therapeutics Inc. began its rolling submission with the U.S. Food and Drug Administration to market its medicine umbralisib as a treatment for two types of blood cancers.
The New York-based biopharmaceutical company is looking to market umbralisib as a treatment for marginal zone lymphoma and follicular lymphoma in patients who did not get better after receiving prior treatment. The drug has the FDA's orphan-drug and breakthrough-therapy designations in the marginal zone lymphoma indication.
The company said it began a single rolling submission, which is expected to be completed in the first half of the year.
TG Therapeutics' executive chairman and CEO, Michael Weiss, said the company is also working to advance other medicines, including a drug called ublituximab to treat multiple sclerosis. The company is also studying umbralisib as a treatment for newer indications.