The European Medicines Agency (EMA) has recommended that pixantrone dimaleate (Pixuvri) be granted conditional approval to treat non-Hodgkin B-cell lymphoma.
The approval is for pixantrone as single-agent therapy for patients with relapsed or refractory lymphoma.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended conditional approval of pixantrone because the data are not yet comprehensive. The CHMP has said more information is needed on the benefits of pixantrone in patients who received prior rituximab.
At the same time, the CHMP 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 of pixantrone will be renewed on a yearly basis until the obligation to provide additional data on rituximab-pretreated patients has been fulfilled. The applicant, CTI Life Sciences Ltd., has said it plans to provide the data by mid-2015.
The main study of pixantrone, the phase 3 EXTEND PIX301 trial, compared the drug to other chemotherapeutic agents in patients with relapsed or refractory non-Hodgkin lymphoma. The rate of response was 20% in the pixantrone arm and 6% in the comparator arm.
In addition, patients receiving pixantrone had longer progression-free survival than patients in the comparator group, with a median of 10.2 months and 7.6 months, respectively.
However, the CHMP noted that the benefit of pixantrone appeared to be lower in patients who had received prior rituximab. And a benefit was not established in patients who had not responded to their last treatment and received pixantrone as the fifth or later round of chemotherapy.
The most common side effects observed with pixantrone were neutropenia, leukopenia, anemia, thrombocytopenia, asthenia, pyrexia, cough, decreased ejection fraction, and nausea. The most common grade 3 and 4 adverse events were hematologic.
The CHMP’s recommendation for conditional approval has been sent to the European Commission for the adoption of a European Union-wide decision. For more information on pixantrone’s approval, visit the EMA website.
