FDA approves IMBRUVICA ® combined ritoxianmono to treat iacoprenoproteinemia in adults
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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Iastinal hyperglobulinemia is a rare, slow-growing and incurable non-Hodgkin's lymphoma with limited treatment options, which usually affects middle-aged and elderly people, although lymph nodes and spleen may also be affected, but are mainly found in the bone marrowrecently, AbbVie announced that the U.SFDA(approved IMBRUVICA ® (Irutinib) combined with RITUXAN ® to treat adult isoprene hyperproteinosis (WM)on the IrutiniIlutinib was first approved as a single-drug treatment for WM in January 2015 and currently receives nine FDA approvals covering six different diseasesthedrug, a pioneering Bruton's tyrosine kinase (BTK) inhibitor developed and commercialized by AbbVie's Pharmacyclicscompany
, and Janssen BioWhether combined with ritoxinocosis or as a single drug, the recommended dose of IMBRUVICA in adult WM patients is 420 mg per day orally once until disease progression or unacceptable toxicity occursrelated research
this new FDA approval is based on clinical phase 3 iNNOVATE (PCYC-1127)trial(data)The efficacy of ilutinib in combination with rituxima was evaluated in 150 patients with previously untreated and recurrent/incurable WM, compared with the use of rituxima monoantigen alone in a 26.5-month median follow-up, the study showed a significant improvement in progression survival (PFS) in patients with elutini-combined rituxima resistance alone compared to the use of rituximamono alone (82% and 28% of 30 months OF PFS), respectively; -0.38, P 0.0001 iNNOVATE is a randomized, placebo-controlled, double-blind clinical phase 3 study sponsored by Pharmacyclics, in which patients were randomly treated with intravenous drips of rituxima resistance 375 mg/m2 once a week for four consecutive weeks, followed by the second three-month, four-time tritoson monoantigen All patients received 420 mg of elutinib or placebo once a day until the standard for permanent discontinuation was met primary endpoint was progression-free survival, while secondary endpoints as a measure of safety and tolerance in each treatment group included overall response rates, blood improvement measured by hemoglobin, duration to next treatment, total lifetime, and number of subjects with adverse events adverse reactions in the study, all the most common adverse reactions in different forms (occurred in 20% or more patients) had bruising (37%), musculoskeletal pain (35%), bleeding (32%), diarrhea (28%), rash (24%), joint pain (24%), nausea (21%) and hypertension (20%)
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