US healthcare giant Johnson & Johnson (NYSE: JNJ) has announced the submission of a Type II variation application to the European Medicines Agency (EMA).
The filing seeks approval for an indication extension of Imbruvica (ibrutinib) alongside rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL), who are eligible for autologous stem cell transplant.
This submission is supported by data from the TRIANGLE study, conducted by the European MCL Network.
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