Ibrutinib receives positive EMA CHMP opinion for an extended indication in frontline mantle cell lymphoma

On June 20, 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the use of ibrutinib in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone), alternating with either R-DHAP (rituximab, dexamethasone, high-dose cytarabine, and cisplatin) or R-DHAOx (rituximab, dexamethasone, high-dose cytarabine, and oxaliplatin) without ibrutinib, followed by ibrutinib monotherapy, for adults with previously untreated mantle cell lymphoma (MCL) eligible for autologous stem cell transplant (ASCT).¹

This recommendation is based on positive results from the randomized, open-label, phase III TRIANGLE study (NCT02858258), previously reported by the Lymphoma Hub. The findings indicated that ibrutinib plus chemotherapy followed by 2 years of ibrutinib maintenance without ASCT resulted in significantly longer overall survival and superior failure-free survival compared with the standard chemotherapy with ASCT approach.¹

The final decision from the European Commission is pending. If approved, the regimen could become a new standard of care for MCL, potentially eliminating the need for ASCT in previously untreated patients eligible for high-dose treatment.¹