Janssen-Cilag International, a Johnson & Johnson company, announces that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the extension of the indication for Imbruvica (ibrutinib) as first-line treatment for mantle cell lymphoma (MCL).

This recommendation is based on results from a pivotal Phase 3 study showing that the addition of ibrutinib to chemotherapy followed by two years of fixed maintenance improves overall survival and failure-free survival compared to treatment including autologous stem cell transplantation (ASCT).

If approved by the EU, ibrutinib would become the first Bruton's tyrosine kinase inhibitor approved as a first-line treatment for transplant-eligible MCL patients, the company said.


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