European approval for ibrutinib plus rituximab for frontline therapy in CLL

On September 7, 2020, the European Commission (EC) approved an extended indication for ibrutinib in chronic lymphocytic leukemia (CLL) to include use in combination with rituximab for previously untreated adult patients. The FDA approved the same extended indication for ibrutinib in April 2020.

Ibrutinib, a first-in-class Bruton’s tyrosine kinase inhibitor, had previously been approved in Europe as a single agent or in combination with obinutuzumab for adult patients with untreated CLL, and as a single agent or in combination with bendamustine and rituximab for adult patients with CLL who had received at least one line of prior therapy. Ibrutinib is also indicated in other hematological malignancies, including mantle cell lymphoma and Waldenström’s macroglobulinemia.

The EC approval for the extended indication is based on data from the phase III E1912 trial (NCT02048813), conducted by the ECOG-ACRIN Cancer Research Group, and sponsored by the National Cancer Institute (NCI). The study showed a significant improvement in progression-free survival for previously untreated patients (≤ 70 years) with CLL who were treated with ibrutinib plus rituximab, compared with patients receiving the standard fludarabine, cyclophosphamide, and rituximab (FCR) regimen. For an expert opinion and more information on this trial see the downloadable resources on the Lymphoma Hub.

This extended indication provides patients with CLL another option of a non-chemotherapy treatment in the frontline setting and will help sparing chemotherapy-induced side effects in these patients.