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2020俄罗斯欧洲杯官网-JJ pushes to expand Imbruvica label after clini

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the current approval only covers the use of Imbruvica as a single agent or in combination with a chemotherapy drug,。

global sales increased by around one third to $2.5bn (€2.2bn). 。

bendamustine, will get approval to sell Imbruvica for use as a first-line treatment in combination with rituximab. JJ is filing to expand the label on the strength of data from a clinical trial that compared Imbruvica and rituximab to the chemo-immunotherapy FCR in 529 previously untreated CLL patients aged 70 years or younger. Progression-free survival at three years in the Imbruvica arm was 89.4%, vice president,2020欧洲杯资讯,2020欧洲杯资讯, said in a statement. That effort gained a boost last year when the US Food and Drug Administration (FDA)approved Imbruvica in combination with Gazyvaro (obinutuzumab) for use as a frontline treatment for CLL. The approval marked the first time a non-chemotherapy-based regimen had been cleared for use in treatment-naive CLL patients and continued a run of label expansions. Imbruvica has received ten FDA approvals since coming to market late in 2013. The label expansions have helped JJ grow sales of the drug over the first nine months of 2019, thereby advancing one of JJ goals for its drug. We remain committed to replacing long-standing use of chemotherapy with ibrutinib-based combination regimens for the treatment of patients with CLL in the frontline setting, and rituximab in patients who have received at least one line of therapy. The filing now awaiting review by the European Medicines Agency (EMA) stands to bring Imbruvica to a new set of patients. If successful,won approval in Europe in 2014. However, JJ thinks it has the evidence to support the use of Imbruvica in frontline settings. The expanded label would also support the use of Imbruvica in a combination that lacks a chemotherapy component, Johnson Johnson has filed for approval of Imbruvica (ibrutinib) in combination with rituximab as a first-line treatment of chronic lymphocytic leukaemia (CLL). Imbruvica,2020欧洲杯官方平台,2020欧洲杯官方网站,2020欧洲杯首页, a Brutons tyrosine kinase (BTK) inhibitor,2020俄罗斯欧洲杯官网,2020欧洲杯首页,2020欧洲杯官方平台,2020欧洲杯首页, clinical development and global medical affairs at Janssen Research Development, Craig Tendler,2020欧洲杯官方网站, as compared to 72.9% in the control cohort. The rates of overall survival at three years in the Imbruvica and control cohorts were 98.8% and 91.5%, respectively. With both results achieving statistical significance,2020欧洲杯官方平台, JJ, through its Janssen unit。

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