J&J: applies to the EMA for an expanded indication for Imbruvica

(CercleFinance.com) - J&J announces that its subsidiary Janssen-Cilag International has applied to the European Medicines Agency to extend the indication of Imbruvica (ibrutinib) in combination with the R-CHOP protocol in the treatment of adult patients with untreated mantle cell lymphoma (MCL) eligible for autologous stem cell transplantation.


This request is based on data from the study conducted by the European MCL Network, including 870 patients divided into three treatment arms.

These results, presented at the ASH 2024 Annual Meeting, suggest that ibrutinib could replace or complement transplant-based protocols, offering options for prolonged remission.

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