Roche Holding AG (RO.EB) said on Friday that the European Union's Committee for Medicinal Products for Human Use has recommended that Alecensa be approved as a first-line treatment for certain patients with non-small cell lung cancer, or NSCLC.
The company says that the recommendation, which is an important step towards obtaining marketing authorization, was made based on the results of a phase 3 trial showing a 53% reduction in the risk of death or worsening of the disease compared with crizotinib drug treatments. The study looked at the use of Alecensa in those patients whose NSCLC was anaplastic lymphoma kinase positive. These patients are particularly likely to develop resistance to the current standard of care within one year of treatment.
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The committee also recommended that a conditional marketing authorization granted in February for the use of the drug in patients whose cancer progressed following treatment with crizotinib, be converted into a full marketing authorization.
According to the World Health Organization, lung cancer is the leading cause of cancer deaths worldwide and NSCLC is one of the most prevalent forms of the disease.
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(END) Dow Jones Newswires
October 13, 2017 09:03 ET (13:03 GMT)