The Transparency Commission of the French National Health Authority has granted market access for Cell Therapeutics' (CTI) aggressive non-hodgkin lymphoma treatment, Pixuvri (pixantrone) in France.
Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma who failed two or three prior lines of therapy.
The company now intends to pursue the final step in France's pharmaceutical reimbursement process of including on the list of medicines approved for hospital use and subsequent publication in the Journal Officiel in France.
CTI president and CEO James Bianco said, "We are pleased to receive the CT's favorable opinion for reimbursement of PIXUVRI and look forward to bringing this new approved therapy to patients in France with aggressive NHL."
The novel aza-anthracenedione is structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite.
With unique structural and physiochemical properties, the investigational agent forms stable DNA adducts and has superior anti-lymphoma activity compared to related compounds in preclinical models.
