Genmab’s CLL drug gets negative opinion from EMA committee

pharmafile | June 24, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing |  Arzerra, CHMP, CLL, EMA, Genmab, blood cancer 

Genmab A/S (Nasdaq Copenhagen: GEN) said its drug Arzerra (ofatumumab) received a negative opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)as maintenance therapy for blood cancer.

Jan van de Winkel, chief executive of Genmab, said: “We are disappointed that we did not receive a positive recommendation for Arzerra in the maintenance CLL setting in Europe.  We will continue to work with Novartis to define the best path forward for Arzerra.”

The MAA was based on positive data from an interim analysis from the Phase III study, which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for relapsed chronic lymphocytic leukemia (CLL). 

A total of 474 patients were included in the analysis. Patients who received ofatumumab maintenance treatment lived 14.2 months longer without their disease worsening than patients who received no further treatment. Median progression free survival (PFS) as assessed by the investigators was 29.4 months for the ofatumumab treatment arm, and 15.2 months for the observation arm, the company said in a statement.

CLL is the most commonly diagnosed adult leukemia in Western countries, and accounts for about 1 in 4 cases of leukemia. Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment.

Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the EU, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Anjali Shukla