European Medicines Agency Recommends to Extend Indications for Ofatumumab

New indication concerns the management of previously untreated patients with chronic lymphocytic leukaemia

On 22 May 2014, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product ofatumumab (Arzerra).

The marketing authorisation holder for this medicinal product is Glaxo Group Ltd. They may request a re-examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The CHMP adopted a new indication as follows: "Previously untreated chronic lymphocytic leukaemia (CLL):

Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy."
Detailed conditions for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

For information, the full indications for ofatumumab will be as follows (new indication in bold):

Previously untreated chronic lymphocytic leukaemia (CLL):

Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.

Refractory CLL:

Arzerra is indicated for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab.