Cell Therapeutics, Inc. (CTI) has announced that the Company has been granted market access by the Italian Medicines Agency (AIFA) for the medicinal product PIXUVRI® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy).
Pixantrone has been classified by AIFA for use in hospitals and additional details on the pricing and reimbursement conditions for PIXUVRI in Italy will be provided coincident with the publication of the "Determina" of AIFA in the Official Gazette, which is expected to take 6 to 8 weeks.
In May 2012, the European Commission (EC) granted conditional marketing authorization in the European Union (E.U.) for PIXUVRI as a monotherapy for adult patients with multiply relapsed or refractory aggressive B-cell NHL based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial.
PIXUVRI was made available to patients in eight countries in the European Union in the fourth quarter of 2012, and some patients in other countries have already started to receive the treatment.
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.