The approval is based on Phase III data from study with ofatumumab + chlorambucil & Phase II data from study with ofatumumab and bendamustine.
"Today's decision by the
"We are very pleased to receive this decision that Arzerra is approved in the EU in the front-line setting in combination with two different alkylating chemotherapies. This is another important milestone and we look forward to a successful launch under this new indication of the drug in
CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately one-third of all cases of leukemia. In
Arzerra (ofatumumab) is a monoclonal antibody that is designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.
Ofatumumab is also authorized in the EU for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
Ofatumumab is being developed under a co-development and collaboration agreement between
Arzerra is a trademark of the GSK group of companies.
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