The Italian Medicines Agency (AIFA) has granted market access to Cell Therapeutics for the medicinal product, Pixuvri (pixantrone), a novel aza-anthracenedione with structural and physiochemical properties
Pixuvri has been approved as a monotherapy to treat adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, including those with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy.
Classified by AIFA for use in hospitals, Pixuvri's pricing and reimbursement conditions in Italy is expected to be provided within the next six to eight weeks.
In May 2012, the European Commission (EC) granted conditional marketing authorization for Pixuvri in the European Union (EU).
Approval in EU was based on the results of the EXTEND, or PIX301 pivotal randomized Phase 3 clinical trial, which was designed using agents in the comparator arm that have anti-tumor activity in relapsed disease and are typically employed as palliative therapy.
