Johnson & Johnson, AbbVie Receive EU Approval for Imbruvica Expansion

Johnson & Johnson and AbbVie's cancer drug Imbruvica has received EU endorsement for its expanded approval from the European Medicines Agency's Committee for Medicinal Products for Human Use. The label expansion was recommended by the advisory committee, paving the way for the drug to be used for an additional indication.

Johnson & Johnson and AbbVie's cancer drug Imbruvica (ibrutinib) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for an expanded indication. The CHMP recommended approval for the use of Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (ibrutinib + R-CHOP) alternating with R-DHAP (or R-DHAOx) without ibrutinib, followed by ibrutinib monotherapy, for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant (ASCT).

This recommendation is based on data from the pivotal Phase 3 TRIANGLE study, which evaluated 870 patients across three treatment arms. The study demonstrated that adding ibrutinib to chemotherapy followed by a 2-year fixed-duration maintenance period instead of ASCT provides significantly longer overall survival and superior failure-free survival compared to the chemotherapy regimen including ASCT [1].

If approved, Imbruvica would become the first Bruton’s Tyrosine Kinase inhibitor (BKTi) for frontline treatment of transplant eligible MCL patients. This expanded indication represents a significant advancement in the treatment of MCL, an aggressive and rare form of non-Hodgkin lymphoma [2].

MCL is a challenging disease to treat, with patients often relapsing or becoming resistant to therapy. The current standard of care in the frontline setting for young and fit patients is a chemotherapy regimen including ASCT, which can be associated with severe toxicities, lengthy hospital stays, and high health resource utilisation [3]. The addition of fixed-duration ibrutinib to chemotherapy offers the potential for long treatment-free remissions while avoiding the burden of stem cell transplant.

Imbruvica is a once-daily oral medication that blocks the BTK protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread. It has been approved in more than 100 countries and has been used to treat more than 325,000 patients worldwide [4].

The CHMP recommendation for ibrutinib is supported by data from the randomised Phase 3 TRIANGLE study, conducted by the European MCL Network (NCT02858258). The study enrolled 870 patients with previously untreated mantle cell lymphoma (MCL) and evaluated three treatment arms to assess whether the addition of ibrutinib to chemotherapy with or without ASCT could improve outcomes and potentially remove the need for transplant in patients with previously untreated MCL who were suitable for high-dose treatment [5].

Johnson & Johnson and AbbVie are committed to improving outcomes for patients facing complex blood cancers. The TRIANGLE study, conducted by the European MCL Network, affirms the potential emergence of a new standard of care for transplant eligible patients diagnosed with MCL and represents the first major step forward for these patients in many years [6].

References:
[1] https://www.jnj.com/media-center/press-releases/imbruvica-ibrutinib-receives-positive-chmp-opinion-for-the-treatment-of-patients-with-previously-untreated-mantle-cell-lymphoma-mcl-who-would-be-eligible-for-autologous-stem-cell-transplant
[2] Jain P. and Wang M. L. Mantle cell lymphoma in 2022-A comprehensive update on molecular pathogenesis, risk stratification, clinical approach, and current and novel treatments, American Journal of Hematology. 2022; 97;5:638–56.
[3] Dreyling, et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 2017; 28:62-71
[4] Monga, N., Garside, J., Davids, M.S. et al. Systematic Literature Review of Economic Evaluations,
[5] ClinicalTrials.gov. ASCT After a Rituximab/Ibrutinib/Ara-c Containing induction in Generalized Mantle Cell Lymphoma. NCT02858258. Available at: https://clinicaltrials.gov/study/NCT02858258 . Last accessed: June 2025.
[6] About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.innovativemedicine.jnj.com/emea . Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea . Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc. and Janssen Research & Development, LLC are Johnson & Johnson companies.