AbbVie's heavy-duty drug Imbruvica and Roche's Rituxan combination therapy get FDA approval

WM is an extremely rare and currently incurable category of non-Hodgkin's lymphoma (NHL), most commonly found in the bone marrow of older adult patients and may also have an effect on the lymph nodes and spleenestimates that 2,800 new cases of WM are needed each year in the United States, and that these patients are in urgent need of a new treatment to reduce the risk of the diseaseToday, AbbVieannounced that its heavy-
drug(ibrutinib) and Roche's Rituxan (rituximab) combined combination therapies werethe FDA (approved for the treatment of the rare blood disease, The Fahrenheit?m's macroglingbulin, WM)IbrutinibIbrutinib is an innovative Bruton's tyrosine kinase (BTK) inhibitor approved for WM monotherapy in January 2015BTK is an important kind of signaling molecule in the human body, which is involved in the receptor signaling pathway of B cells, which is very important for the survival and diffusion of malignant B cellsBy inhibiting BTK, ibrutinib inhibits the uncontrolled proliferation of B cells, thus controlling the condition of many blood cancersrelated studies
this approval is based on a phase 3 phase double-blindtrial(results) that compare the efficacy of ibrutinib-rituximab combination therapy and rituximab monotherapyin the trial, 150 recurrent/refractory WM patients were randomly divided into two groups, one receiving a combination of rituximab and ibrutinib (420 mg) and the other receiving a single drug treatment of rituximabIn the 26.5 months, the non-progressive survival rate (PFS rate) results were significantly better than those in the patient group of combination therapy in the 30th month, the non-progressive survival rate for patients with combination therapy was 82 percent, compared with 28 percent for single-drug therapy patients In addition, the risk of deterioration or even death in patients with combination therapy was reduced by 80% compared to single-drug therapy patients