EMA recommends conditional approval for Pixuvri

The EMA has granted conditional approval for Pixuvri (pixantrone dimaleate) – the first treatment for non- Hodgkin’s B-cell lymphoma in patients whose cancer has returned.

The CHMP recommended the use of the treatment in patients whose cancer is aggressive and has returned after multiple rounds of chemotherapy or is not responding to other treatments.

Pixuvri, the Committee says, satisfies an unmet medical need and the benefits of the medicine outweigh the risks despite the need for additional data in patients who have previously received MabThera (rituximab).

The initial main study demonstrated that Pixuvri’s benefits outweigh its risks. Data highlighted how a greater number of patients responded to the drug than a comparator chemotherapy, and that individuals receiving Pixuvri went an average of 10.3 months longer without their disease getting worse.

The Committee also noted that the benefit appeared to be lower in patients who had previously received MabThera and that its benefit was not established in patients when used as the fifth or later round of chemotherapy in those whose disease had not responded to treatment.

Pixuvri’s conditional approval will now continued to be monitored on an annual basis until the data on MabThera-pretreated patients has been conducted and presented. This information is expected in 2015.

The CHMP’s decision has now been sent to the European Commission for the adoption of an EU-wide decision.