Genmab and Novartis look for the European approval of their leukemia candidate

genmab JJ daratumumab

Genmab is seeking the European authorization for Arzerra, a treatment co-developed with Novartis. The submission is based on the candidate’s positive results in its Phase III in patients with leukemia.

Arzerra, the commercial name for ofatumumab, is a human monoclonal antibody that directs the body’s immune system to fight normal and cancerous B-lymphocytes. The drug candidate attaches to the molecule found on the surface of the lymphocytes, the type of cell which becomes cancerous in chronic lymphocytic leukemia. With these types of cancer, B-cells can overproliferate and the treatment, which works as a pointer, is needed to reduce their number.

The approach was supported by a successful Phase III to study the drug candidate as maintenance therapy for patients with relapsed chronic lymphocytic leukemia, the most commonly diagnosed adult leukemia in Western countries. Sadly, most patients suffering from this cancer experience disease progression despite the initial response to therapy and may require additional treatment. And this is where Arzerra comes to play.

The drug was originally developed as part of the collaboration between Genmab and GlaxoSmithKline. However, with the internal restructuration of GSK’s activities, the company decided to drop its entire cancer program that was bought by voracious Novartis. The UK giant, however, retained the ofatumumab rights for autoimmune indications although it is Novartis who will exploit the drug’s potential in oncology.

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