Johnson & Johnson's (JNJ) Janssen-Cilag International unit said Wednesday that the European Commission has approved an indication extension of Imbruvica, or ibrutinib, in frontline mantle cell lymphoma, or MCL, an aggressive and incurable form of blood cancer.
The approved regimen includes ibrutinib, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone alternating with R-DHAP or R-DHAOx without ibrutinib, followed by ibrutinib monotherapy to treat adults with previously untreated MCL who are eligible for autologous stem cell transplant, the company said.
The approval was backed by data from a phase 3 trial conducted by the European MCL Network, the company added.
After a median follow-up of 55 months, the study showed that ibrutinib combined with chemoimmunotherapy led to "significantly superior" failure-free survival even without the need for transplant, the company said.
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