The CHMP has issued a positive opinion for GlaxoSmithKline and Genmab’s Arzerra (ofatumumab) for the treatment of refractory chronic lymphocytic leukaemia (CLL).
The CHMP has recommended that the drug is granted a conditional marketing authorisation in the EU for the treatment of patients who are refractory to fludarabine and alemtuzumab, the standard therapies currently used to treat CLL.
CLL is a cancer of the blood and bone marrow. The disease is termed refractory when patients do not respond to treatment, and at this stage there are limited treatment options and poor outcomes with existing treatments.
A conditional marketing authorisation is granted to a drug with a positive benefit/risk assessment that fulfils an unmet medical need. These are granted when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required.
As part of the conditions of the conditional marketing authorisation for ofatumumab, GSK will be required to provide further data.