Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

Market Access Granted in France for Aggressive NHL Treatment, PIXUVRI®

Published: Wednesday, August 21, 2013
Last Updated: Tuesday, August 20, 2013
Bookmark and Share
CT will reassess the ASMR rating for PIXUVRI within two years.

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.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,600+ scientific posters on ePosters
  • More than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

CTI Opens Enrollment for PERSIST-2 Phase 3 Trial of Pacritinib for Myelofibrosis Patients
This trial, together with PERSIST-1, to support registration in the U.S. and Europe.
Tuesday, March 04, 2014
CTI Announces UK NCRI AML Cooperative Group Phase 2 Trial Evaluating Pacritinib for AML Patients
Trial sponsored by Cardiff University and supported by Cancer Research UK.
Tuesday, February 04, 2014
CTI Announces GOG Completes Patient Enrollment in GOG-0212
Patient enrollment in Phase 3 clinical trial of Opaxio™ as maintenance therapy in ovarian cancer.
Thursday, January 30, 2014
CTI Reaches Agreement with Novartis
Agreement to reacquire rights to two anti-cancer compounds.
Monday, January 13, 2014
CTI Announces Removal of the Partial Clinical Hold on Tosedostat
Company has received notification from the U.S. Food and Drug Administration.
Thursday, January 02, 2014
CTI and GKV-SV Reach Agreement on Pricing of PIXUVRI® (pixantrone) in Germany
Decision applies to patients with aggressive B-cell non-Hodgkin lymphoma who have failed two or three prior lines of therapy.
Wednesday, December 04, 2013
CTI Announces Data Presentations at the 55th ASH Annual Meeting
Pacritinib phase 2 analysis of myelofibrosis patients with thrombocytopenia (low platelets) accepted for oral presentation.
Monday, November 11, 2013
Cell Therapeutics Announces Agreement with the FDA on SPA for PERSIST-2 Trial
PERSIST-2 trial expected to initiate in fourth quarter of 2013.
Tuesday, October 08, 2013
CTI Announces Results from Sub-Set Analyses of Data from Phase 3 EXTEND Clinical Trial
Results presented at 18th Congress of the European Hematology Association.
Monday, July 15, 2013
Market Access Granted in Italy for PIXUVRI®
Access granted by AIFA for the aggressive non-Hodgkin lymphoma treatment.
Monday, July 08, 2013
Comprehensive Summary of Preclinical and Clinical Data for Pacritinib Published
Comprehensive article was published in the journal Drugs of the Future 2013.
Thursday, July 04, 2013
Cell Therapeutics Announces Resignation of Chief Medical Officer
Resignation of Steven E. Benner for personal reasons.
Monday, July 01, 2013
CTI Secures $15 Million Loan Financing Agreement
Company has entered into loan agreement with HTGC.
Tuesday, May 28, 2013
G-BA Issues Final Assessment Report for PIXUVRI®
Pricing negotiations to begin in June.
Tuesday, May 21, 2013
Tosedostat OPAL Study in Acute Myeloid Leukemia Published in Lancet Oncology
Lancet Oncology has published results from the OPAL Phase 2 study of tosedostat.
Tuesday, March 05, 2013
Scientific News
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
Antibody Treatment Efficacious in Psoriasis
An experimental, biologic treatment, brodalumab, achieved 100 percent reduction in psoriasis symptoms in twice as many patients as a second, commonly used treatment, according to the results of a multicenter clinical trial led by Mount Sinai researchers.
Scientists Test New Gene Therapy for Vision Loss from a Mitochondrial Disease
NIH-funded study shows success in targeting mitochondrial DNA in mice.
HIV Patients Should Be Included in Early Clinical Trials of Anti-TB Drugs
Tuberculosis is the number one cause of death in HIV-infected patients in Africa and a leading cause of death in this population worldwide.
Multi-Gene Test Enables Some Breast Cancer Patients to Safely Avoid Chemotherapy
A major study is providing the best evidence to date that a 21-gene test done on the tumor can identify breast cancer patients who can safely avoid chemotherapy.
Low Dose Beta-Blockers As Effective As High Dose After a Heart Attack?
Heart attack patients live as long – or even longer – on one-quarter the suggested dose.
Antidepressants Plus Blood-Thinners Slow Down Brain Cancer
EPFL scientists have found that combining antidepressants with anticoagulants slows down brain tumors (gliomas) in mice.
Old Drug Performs New Tricks
Cambridge-led research reveals the powers of a "wonder drug" that has lain under the noses of doctors for 50 years.
Electronic Reminders Keep TB Patients on Track With Medication In China
Giving electronic reminders to tuberculosis (TB) patients in China can reduce the amount of medication doses they miss by half, according to new research.
Scroll Up
Scroll Down

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos