CTI BioPharma Corp.has announced the completion of enrollment in the Phase 3 PIX306 trial of Pixuvri (pixantrone). The PIX306 trial is evaluating Pixuvri combined with rituximab in comparison to that of rituximab combined with gemcitabine in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). Patients eligible to be enrolled in the trial had failed front line CHOP-R and were not eligible for autologous stem cell transplant (ASCT) (2nd line) or failed ASCT (3rd or 4th line).
Pixuvri has previously been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The trial is being conducted as a post-authorization requirement of conditional marketing authorization. If positive, the results from this trial could support broader indications. Top-line results are event-driven and are expected in the first half of 2018.
Pixuvri is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells in B-cell NHL cannot divide and eventually die.
Pixuvri is conditionally approved in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The benefit has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.
The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication
Cti biopharma, completes patient enrollment, pixuvri for aggressive b-cell nhl
