Arzerra (ofatumumab) filed in EU for maintenance in relapsed CLL- Genmab/Novartis

Genmab announced that a variation to the Marketing Authorization has been submitted to the European Medicines Agency (EMA) for the use of Arzerra (ofatumumab) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL). The application is based on interim results from a Phase III study, PROLONG (OMB112517) which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second- or third-line treatment for CLL. Results from this trial were presented at the 2014 American Society of Hematology Annual Meeting.

Comment: In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab. Arzerra is not approved anywhere in the world as maintenance therapy for relapsed chronic lymphocytic leukemia.