The approval is for ibrutinib 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 MCL who would be eligible for autologous stem cell transplant (ASCT).
Ibrutinib is a once-daily oral medication that is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.1 Ibrutinib blocks the BTK protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread.4 By blocking BTK, ibrutinib may help move abnormal B-cells out of their nourishing environments and inhibits their proliferation.
“MCL is still an aggressive, incurable disease and patients suffer under the burden associated with transplant,” said Martin Dreyling, M.D., Ph.D., Ludwig Maximilian University of Munich.** “As a targeted therapy, ibrutinib represents an opportunity to improve long term outcomes earlier in the treatment pathway. Patients now have a new standard of care in first line treatment that not only offers prolonged survival but also avoids short and long-term toxicities associated with high-dose chemotherapy and autologous stem cell transplant.”
“For more than a decade, ibrutinib has been the standard of care in relapsed or refractory MCL, transforming patient outcomes in later lines. Today’s approval for frontline use offers patients facing this aggressive blood cancer improved survival outcomes from the outset of treatment,” said Ester in ‘t Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. “This milestone reinforces our commitment to evolving treatment paradigms in haematological malignancies through targeted, science-driven innovation.”
The approval for ibrutinib is supported by data from the open-label, randomised, Phase 3 TRIANGLE study conducted by the European MCL Network (NCT02858258). It evaluated 870 patients across three treatment arms to assess whether the addition of ibrutinib to chemoimmunotherapy (CIT) with or without ASCT could improve outcomes, when compared to ASCT + CIT alone, and potentially remove the need for transplant in patients with previously untreated MCL who were eligible for ASCT. At a median follow-up of 55 months, the findings demonstrated that treatment with ibrutinib plus CIT delivered significantly superior failure-free survival (FFS) while omitting the burden of ASCT (77 percent vs 68 percent at 54-months respectively; hazard ratio [HR], 0.639; 98 percent confidence interval [CI], 0.428–0.953; two-sided p=0.0068) and that ibrutinib + CIT provided significantly longer overall survival versus ASCT plus CIT (88 percent vs 78 percent at 54-months respectively; HR, 0.522; 95 percent CI, 0.341–0.799; two-sided p=0.0023).
The overall safety profile of the ibrutinib + CIT regimen was consistent with the previously known safety profile of ibrutinib.
“Until now, fit patients with mantle cell lymphoma have only had the option of frontline treatment with ASCT and chemotherapy. We’re incredibly proud that with this approval, ibrutinib has become the first alternative therapy for this patient population after demonstrating superior outcomes compared to the current standard of care,” said Jessica Vermeulen, Vice President, Lymphoma & Leukemia Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “This approval reinforces our ongoing commitment to haematological malignancies, and the power of our collaborations with academics and researchers to bring cutting edge science to areas of high unmet need.”
Ibrutinib is approved in more than 100 countries and has been used to treat more than 325,000 patients worldwide.6 There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of ibrutinib.1,7 In October 2021, ibrutinib was added to the World Health Organization’s Model Lists of Essential Medicines (EML), which refers to medicines that address global health priorities and which should be available and affordable for all.8
Ibrutinib was first approved by the European Commission (EC) in 2014, and approved indications to date include:
- As a single agent or in combination with rituximab or obinutuzumab or venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
- As a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
- As a single agent for the treatment of adult patients with relapsed or refractory MCL
- As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. In combination with rituximab for the treatment of adult patients with WM
- In combination with R-CHOP alternating with R-DHAP (or R-DHAOx)* without ibrutinib, followed by ibrutinib monotherapy, for the treatment of adult patients with previously untreated MCL who would be eligible for autologous stem cell transplant
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