Cell Therapeutics, Inc. has reported 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 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).
The next and final step in France's pharmaceutical reimbursement process is inclusion on the list of medicines approved for hospital use and subsequent publication in the Journal Official in France, which CTI now intends to pursue.
"The availability of PIXUVRI in France means physicians will be able to extend an approved salvage regimen to those patients that fail second line therapy," said Gilles Salles, M.D., PhD., Professor of Medicine at the University Claude Bernard Lyon-1 and President of LYSA, the Lymphoma Study Association.
"The data from the pivotal EXTEND study of PIXUVRI clearly indicate that this drug is effective in heavily pretreated patients with relapsed or refractory aggressive NHL," commented Bertrand Coiffier, M.D., Professor of Haematology at the Department of Haematology, Hospices Civils de Lyon and the University Claude Bernard, Lyon, France.
The CT noted that aggressive NHL is a serious disease and that there are no standard treatments for patients with this stage of disease.
All registered pharmaceuticals in France are subjected to an evaluation process known as Evaluation of Therapeutic Benefit (Amelioration du Service Medical Rendu, or ASMR) by the CT, with the resulting evaluation expressed as a classification between 1 and 6.
The CT rated PIXUVRI at level 5, which allows PIXUVRI to be included in the reimbursed drugs list for hospital use.
"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," said James A. Bianco, M.D., President and CEO of CTI.
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.