The European Medicines Agency grants a conditional marketing authorisation for ofatumumab for the treatment of patients with chronic lymphocytic leukaemia who are refractory to fludarabine and alemtuzumab

Meeting highlights from the Committee for Medicinal Products for Human Use, 18-21 January 2010

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted at its January 2010 meeting a positive opinion, recommending the granting of a conditional marketing authorisation, for ofatumumab (Arzera), from Glaxo Group Ltd, intended for the treatment of patients with chronic lymphocytic leukaemia who are refractory to fludarabine and alemtuzumab. The review for ofatumumab began on 25 February 2009 with an active review time of 188 days. Ofatumumab is the 62nd orphan medicinal product to receive a positive opinion by the CHMP.

A marketing authorisation under conditional approval means that further evidence on the medicinal product is awaited. In the case of ofatumumab this relates to clinical data on the long term use of ofatumumab in the double (fludarabine and alemtuzumab) refractory population and comparative clinical data on the use of ofatumumab in the fludarabine-refractory, bulky lymphadenopathy population (patients ineligible for alemtuzumab). The European Medicines Agency will review new information within one year and update the product information as necessary.