Janssen, Pharmacyclics submit cancer drug ibrutinib for FDA approval

07/12/2013 | PharmaTimes (U.K.)

Johnson & Johnson's Janssen Biotech and Pharmacyclics have filed an application with the FDA for approval to market their experimental drug ibrutinib for treatment of mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma using data from two midstage studies. Ibrutinib was granted breakthrough therapy designations for three indications by the FDA.

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