US FDA approves Genmab’s ofatumumab for relapsed CLL

31 August 2016 (Last Updated August 31st, 2016 18:30)

Danish biotechnology company Genmab has received the US Food and Drug Administration (FDA) approval for ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) to treat relapsed chronic lymphocytic leukaemia (CLL).

Danish biotechnology company Genmab has received the US Food and Drug Administration (FDA) approval for ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) to treat relapsed chronic lymphocytic leukaemia (CLL).

CLL is said to be the most commonly diagnosed adult leukaemia in western countries. The majority of CLL patients experience disease progression despite their initial response to therapy and may require additional treatment.

Ofatumumab is a human monoclonal antibody designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.

The latest approval is based on the results from a Phase III COMPLEMENT 2 study.

"This is the fourth CLL indication approved in the US for Arzerra, and we are pleased to see the availability of this treatment expand to a wider number of patients."

During the open-label, two-arm randomised study, 365 patients with relapsed CLL in 18 countries were administered ofatumumab in combination with FC or with fludarabine and cyclophosphamide alone.

Genmab CEO Jan van de Winkel said: "This is the fourth CLL indication approved in the US for Arzerra, and we are pleased to see the availability of this treatment expand to a wider number of patients.”

Arzerra is currently approved for use in combination with chlorambucil to treat previously untreated patients with CLL in the US.

It is used in combination with chlorambucil or bendamustine in the European Union.

Additionally, Arzerra is used as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab in more than 50 countries worldwide.

Arzerra is marketed under a collaboration agreement between Genmab and Novartis.

Under the agreement, Novartis has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.