白血病 z-bo 2020-10-23 401

　　TGTherapeutics is a biopharmaceutical company dedicated to the development of innovative therapies for B cell-mediated diseases. Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track Qualification (FTD) for the combined use of ubrituximab and umbralisib (U2) to treat adult chronic lymphocytic leukemia (CLL).

　　Fast Track Qualification (FTD) aims to accelerate drug development and rapid review of serious diseases to address unmet serious medical needs in key areas. Obtaining fast-track qualifications for laboratory drugs means that pharmaceutical companies can interact with the FDA more frequently during the development phase. After submitting the marketing application, if it meets the relevant standards, it will be approved and prioritized for review. You also need to scroll through. Ublituximab is a new type of sugar chain engineered anti-CD20 monoclonal antibody that targets a unique epitope of CD20 antigen on mature B lymphocytes. Umbralisib is a new-generation PI3Kδ inhibitor that is taken orally once a day. It can uniquely inhibit CK1-ε and overcome some of the drug resistance issues related to the first-generation PI3Kδ inhibitor.

　　If the list is approved, U2 will provide new chemotherapy-free regimens for CLL patients who have not previously received treatment (initial treatment) and CLL patients who have not responded to previous treatment or have relapsed.

　　FDA approved the U2 combination therapy FTD based on the positive results of the global phase III UNITY-CLL trial. The study was conducted in patients with untreated (untreated) and relapsed/refractory (treated) chronic lymphocytic leukemia (CLL). We evaluated the efficacy and safety of U2 combination therapy and compared it with obinutuzumab + butyl nitrobenzoate and the mustard plan.

　　The examination is conducted under the Special Program Evaluation (SPA) contract with the FDA. The results showed that the study reached the pre-specified primary endpoint of the interim analysis. According to the assessment of the Independent Review Committee (IRC), the progression-free survival rate (PFS) of the U2 treatment group was compared with the obinutuzumab + chlorbenzamide treatment group. A statistically significant improvement (p\u003c0.0001) was achieved in both previously untreated (initial treatment) and relapsed/refractory (treatment) CLL patients, and the treatment effect was observed.

　　According to the trial data, TG will submit the U2 plan by the end of 2020 to treat patients with untreated (initial treatment) and relapsed/refractory (treatment) CLL. Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia, and it is estimated that by 2020, more than 20,000 new cases of CLL will be diagnosed in the United States. After the first treatment, the symptoms of CLL may disappear for a while, but the disease is considered incurable, and many people need other treatments to make the malignant cells recur. Ublituximab is a new type of sugar chain engineered anti-CD20 monoclonal antibody that targets a unique epitope of CD20 antigen on mature B lymphocytes. This epitope is different from many CD20 monoclonal antibodies currently on the market, such as ofatumumab and ocrelizumab/. Ribiximab, Obinutsumab (GA101). Ubituximab is currently in phase III clinical development for the treatment of multiple sclerosis (MS) and chronic lymphocytic leukemia (CLL). Umbralisib is a dual-acting inhibitor of phosphoinositide 3-kinase delta (PI3K delta) and casein kinase 1 epsilon (CK-1 epsilon), and may be able to overcome some of the resistances associated with first-generation PI3K delta inhibitors. there is a question. Phosphatidylinositol 3-kinase (PI3K) is a class of enzymes involved in cell proliferation and survival, cell differentiation, intracellular transport and immunity. PI3K has four subtypes (α, β, δ, and γ), among which the δ subtype is strongly expressed in cells of hematopoietic origin and is usually associated with B cell-related lymphoma. Ubrabu has nanomolar potency for PI3Kδ subtypes and highly selective for α, β and γ subtypes. Ambrassive also independently inhibits casein kinase 1-ε (CK1-ε). It may have a direct anti-cancer effect, and it can also modulate T cell activity associated with immune-mediated adverse events previously observed with PI3K inhibitors. The currently approved PI3Kδ inhibitors are related to autoimmune-mediated toxicity, such as liver toxicity, pulmonary toxicity, and colitis. Compared with approved PI3K inhibitors, umbralisib's specificity, its unique inhibitory effect on CK1-ε, and its unique patented structure have different characteristics in the PI3K inhibitor category.

　　In August of this year, the US FDA approved a new drug application for umbralisib for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL), and a priority review was conducted.