Pixurvi Moves Closer to Market in France

Cell Therapeutics (CTI) is reporting that the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante or HAS) has granted market access to CTI for its oncology product Pixurvi (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.

All that CTI needs now is to see to it that Pixurvi is included on the French list of medicines approved for hospital use and subsequent publication in the Journal Officiel in France. It will then qualify for the pharmaceutical reimbursement process in that country.

Opinions of Pixurvi

Gilles Salles, M.D., Ph.D., professor of medicine at the University Claude Bernard Lyon-1 and president of LYSA, the Lymphoma Study Association said:

The availability of Pixurvi in France means physicians will be able to extend an approved salvage regimen to those patients that fail second line therapy.

Bertrand Coiffier, M.D., professor of haematology at the Department of Haematology, Hospices Civils de Lyon and the University Claude Bernard, Lyon, France, added:

The data from the pivotal Extend study of Pixurvi clearly indicate that this drug is effective in heavily pretreated patients with relapsed or refractory aggressive NHL.

Said James A. Bianco, M.D., the much criticized President and CEO of CTI:

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.

Pixurvi received conditional marketing authorization in the European Union (E.U.) in May 2012 thanks to a ruling by the European Commission (EC).

Source: CTI