EMA Recommends Extension of Therapeutic Indications for Ofatumumab

New indication concerns the treatment of relapsed CLL

On 10 November 2016, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product ofatumumab (Arzerra).

The marketing authorisation holder for this medicinal product is Novartis Europharm Ltd.

The CHMP adopted an extension to the existing indication 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.

Relapsed CLL:

Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL.

Refractory CLL:

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

Detailed recommendations 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 a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.