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TG Therapeutics announced that the U.S. Food and Drug Administration (FDA) has awarded fast-track designations for the treatment of chronic lymphoblastic leukemia (CLL) in adults by combining its sugar-engineered anti-CD20 monoantilituximab with the oral dual inhibitors umbralisib of PI3K-δ and CK1-epsilon.
the fast-track designation is based on UNITY-CLL Phase III research data, which show that the ulituximab joint umbralisib has reached the main end of progress-free survival.
S. Weiss, Executive Chairman and CEO of TG Therapeutics, said: "We are very pleased to receive the fast-track certification of the Ulituximab joint ubralisib (U2 combination) treatment for adult CLL.
this designation can help us accelerate U2 development and regulatory review, and highlight the medical needs of CLL patients.
" chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults.
estimates that more than 20,000 new CLL cases will be diagnosed in the United States by 2020.
although the signs of CLL may disappear for some time after initial treatment, the disease is considered incurable and many people still need other treatments due to the regeneration of malignant tumor cells.
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