Cell Therapeutics, Inc. (CTI) has announced that it has concluded an agreement with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) in Germany for PIXUVRI® (pixantrone).
PIXUVRI is the first medicinal product approved in the European Union (E.U.) for patients with aggressive B-cell non-Hodgkin lymphoma (NHL) who have failed two or three prior lines of therapy.
"We are pleased to have reached an agreement with the GKV-SV on the reimbursement price of PIXUVRI so that hematologists in Germany may continue to treat patients with the only approved treatment for this aggressive disease," said James A. Bianco, M.D., President and Chief Executive Officer of CTI.
Bianco continued, "PIXUVRI is the first medicinal product approved in the E.U. for the treatment of patients with aggressive non-Hodgkin B-cell lymphoma who have failed two or three prior lines of therapy, which was based on results from the only Phase 3 trial conducted in this patient population. Given the response rates seen in this trial, PIXUVRI may provide an effective salvage or palliative treatment option for this patient population where there are no other approved agents. The conclusion of these pricing negotiations brings welcome clarity and confidence to German physicians regarding the reimbursement status of PIXUVRI."
PIXUVRI is already available in Germany for healthcare professionals to prescribe in accordance with local guidance. In May 2012, the European Commission granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial.
Prior to the approval of PIXUVRI in the E.U., there were no approved agents or standard of care in this disease. The PIX301 trial was designed utilizing agents in the comparator arm that have anti-tumor activity in relapsed disease and are typically employed as palliative therapy for these patients.
The results of the pivotal Phase 3 trial were published in Lancet Oncology and can be accessed at http://www.celltherapeutics.com/publications. The benefit of PIXUVRI treatment 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. The SmPC is available at www.pixuvri.eu.
CTI is currently accruing patients into a Phase 3 trial comparing PIXUVRI and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. PIXUVRI does not have marketing approval in the United States.