On January 9, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation covering the combination of TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 the Company’s oral, next generation PI3K delta inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, JAN 9, 2017, View Source [SID1234517334]). The combination of TG-1101 and TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL as well as the UNITY-DLBCL Phase 2b Trial for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Schedule your 30 min Free 1stOncology Demo! "Receiving orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 provides another layer of exclusivity protection on top of the composition of matter patents which were issued for TG-1101 and TGR-1202 last year and patents on the combination that have been filed and are pending approval," stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. "Additionally, with enrollment into our UNITY-CLL Phase 3 trial currently exceeding our expectations, we expect to be able to commence a regulatory filing for the combination in 2018 and having orphan drug designation will provide certain cost saving advantages for us during the regulatory approval process."
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ABOUT ORPHAN DRUG DESIGNATION
Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.
ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). CLL usually gets worse slowly and is one of the most common types of leukemia in adults. It often occurs during or after middle age. It is estimated that there are approximately 20,000 new cases of CLL diagnosed each year in the United States.