The FDA granted breakthrough therapy status to Janssen Biotech and Pharmacyclics' ibrutinib, a Bruton's tyrosine kinase inhibitor, as a treatment for relapsed or refractory mantle cell lymphoma and Waldenström's macroglobulinemia. The companies plan to submit the drug for approval for mantle cell lymphoma in 2013.
Janssen-Pharmacyclics lymphoma drug gets breakthrough status
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