The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended that pixantrone (Pixuvri®) be granted conditional approval for non-Hodgkin’s B-cell lymphoma. The conditional approval covers use of pixantrone as monotherapy in patients whose cancer is aggressive and has relapsed or is refractory.

Conditional approval was recommended by the CHMP as the data provided show that the pixantrone’s benefits outweigh its risks but are not yet comprehensive, and that more information is needed on the benefits of the medicine in patients who have received rituximab in the past. At the same time, the Committee concluded that pixantrone satisfies an unmet medical need, because there are no approved and standard treatments for this stage of the disease. Therefore, the benefits of making this medicine available on the market immediately outweigh the risks inherent in the fact that additional data are required.

The conditional approval will be renewed on a yearly basis until the obligation to provide additional data on rituximab-pretreated patients has been fulfilled. The company has informed the CHMP that it expects to be able to provide the results of the additional study by mid-2015.

The most frequent side effect seen in the clinical studies was suppression of the bone marrow, resulting in low levels of white blood cells, platelets and red blood cells. Infections were common, but were only serious in a few patients.

The CHMP’s recommendation will now be sent to the European Commission for the adoption of an EU-wide decision.