New drug for lymphoma! TG's new PI3K inhibitor umbralisib has been awarded a breakthrough drug by the FDA

TG Therapeutics is a biopharmaceutical company dedicated to developing innovative therapies for patients with B-cell-mediated diseases. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has granted umbralisib (TGR-1202) treatment for breakthrough drug eligibility (BTD) for adult patients with marginal lymphoma (MZL) who have previously received at least one anti-CD20 program.
MZL is a rare and incurable type of B-cell non-Hodgkin's lymphoma that originates in the edge of lymphatic tissue and grows slowly. In January 2017, Johnson and Johnson targeted the cancer drug Imbruvica (ibrutinib) with FDA approval to accelerate approval for MZL adult patients who have previously received at least one anti-CD20 program. But so far, the drug for MZL has not been fully approved by regulators.
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases, and there is preliminary clinical evidence that the drug can substantially improve the condition compared to existing treatments. Access to BTD drugs can be developed with closer guidance, including from senior FDA officials, to ensure that new treatment options are available to patients in the shortest possible time.
grant of this BTD is based on the ongoing evaluation of umbralisib single-drug IIb phase registration guidance clinical study UNITY-NHL MZL queue interim data. "We look forward to working closely with the FDA to bring our new PI3K inhibitor umbralisib to patients as soon as possible," said Michael S. Weiss, Executive Chairman and CEO of TG. Currently, MZL patients who have failed to receive initial chemotherapy-immunotherapy have very limited drug options, and we believe that umbralisib can meet the significant unsuperfyed medical needs that exist in this area. The MZL single-drug umbra treatment queue for the NITY-NHL study has completed the patient group, and we look forward to publishing the top-line data for the queue by the middle of this year and at a major medical conference in 2019.
umbralisib is an oral, daily PI3K inhibitor that uniquely inhibits CK1-ε, which may enable it to overcome some of the tolerance problems associated with first-generation PI3K pyride inhibitors.
In addition to umbralisib, TG is also developing a single anti-drug ulituximab (TG-1101), a glycically chimeg IgG1 monoclonal antibody targeting CD20, which is being evaluated for cancer treatment (chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL) and non-phosphagia (NHL) adaptations). TG is currently waiting for key data from these studies.
addition, TG recently advanced its PD-L1 monoantigen TG-1501 and its co-priced combination bruton tyrosine kinase (BTK) inhibitor TG-1701 to Phase I clinical development, and plans to advance more pipeline assets to clinical development in the future. (Bio Valley)