The FDA granted breakthrough therapy status to Novartis' LDK378 for treatment of patients with anaplastic lymphoma kinase positive metastatic nonsmall-cell lung cancer when crizotinib can't be used. The drug is being tested in two midstage trials, and Novartis plans to initiate several late-stage studies this year. An initial regulatory application is expected early next year.
Novartis' lung cancer drug gets breakthrough designation
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