Imbruvica Approved in EU for First-Line MCL as Stem Cell Alternative

Johnson & Johnson announced that the European Commission has approved a new use for its BTK inhibitor, Imbruvica (ibrutinib), as a first-line treatment alternative to autologous stem cell transplant (ASCT) for patients with mantle cell lymphoma (MCL). This approval allows the use of ibrutinib in combination with a regimen of rituxan, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), which alternates with rituximab, dexamethasone, high-dose cytarabine, and cisplatin or oxaliplatin (R-DHAP/R-DHAOx) without Imbruvica. Subsequently, patients are to receive Imbruvica as maintenance therapy, specifically targeting previously untreated patients who are eligible for ASCT.

Ester in 't Groen, the EMEA therapeutic area head of hematology at Johnson & Johnson Innovative Medicine, highlighted that this new approval for frontline use provides patients with improved survival outcomes from the beginning of their treatment. The recent decision by the European Commission follows a positive recommendation from the EU drug advisory panel in the previous month.

This label expansion is supported by data from the Phase III TRIANGLE study. The trial demonstrated that the combination of Imbruvica with chemoimmunotherapy (CIT), whether or not ASCT was included, significantly enhanced failure-free survival and overall survival rates. Specifically, at 54 months, the study revealed that the combination of Imbruvica and CIT yielded a failure-free survival rate of 77% compared to 68% for ASCT plus CIT. Similarly, overall survival was 88% for the Imbruvica group versus 78% for the ASCT group.

Imbruvica was first authorized in the European Union in 2014 and has been approved for various conditions, including mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström’s macroglobulinemia. These approvals cover its use as monotherapy as well as in combination with chemotherapy and targeted therapies.

Earlier this year, the European Commission also approved another BTK inhibitor, AstraZeneca's Calquence (acalabrutinib), in combination with bendamustine and rituximab. It was approved as a first-line treatment option for patients with mantle cell lymphoma who are ineligible for ASCT.

The approval of Imbruvica as an alternative to ASCT for previously untreated, ASCT-eligible patients with MCL adds an important option for healthcare providers and patients. By improving survival outcomes right from the start, it addresses a significant need in the management of this aggressive type of lymphoma. Imbruvica’s ability to be used alongside established chemoimmunotherapy regimens enables a more individualized approach to treatment, potentially leading to better patient outcomes. The ongoing research and development by companies like Johnson & Johnson continue to play a crucial role in expanding and improving cancer treatment options, providing hope for patients battling these challenging diseases.