Satellite Banner
Genomics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

CTI and GKV-SV Reach Agreement on Pricing of PIXUVRI® (pixantrone) in Germany

Published: Wednesday, December 04, 2013
Last Updated: Wednesday, December 04, 2013
Bookmark and Share
Decision applies to patients with aggressive B-cell non-Hodgkin lymphoma who have failed two or three prior lines of therapy.

Cell Therapeutics, Inc. (CTI) has announced that it has concluded an agreement with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) in Germany for PIXUVRI® (pixantrone).

PIXUVRI is the first medicinal product approved in the European Union (E.U.) for patients with aggressive B-cell non-Hodgkin lymphoma (NHL) who have failed two or three prior lines of therapy.

"We are pleased to have reached an agreement with the GKV-SV on the reimbursement price of PIXUVRI so that hematologists in Germany may continue to treat patients with the only approved treatment for this aggressive disease," said James A. Bianco, M.D., President and Chief Executive Officer of CTI.

Bianco continued, "PIXUVRI is the first medicinal product approved in the E.U. for the treatment of patients with aggressive non-Hodgkin B-cell lymphoma who have failed two or three prior lines of therapy, which was based on results from the only Phase 3 trial conducted in this patient population. Given the response rates seen in this trial, PIXUVRI may provide an effective salvage or palliative treatment option for this patient population where there are no other approved agents. The conclusion of these pricing negotiations brings welcome clarity and confidence to German physicians regarding the reimbursement status of PIXUVRI."

PIXUVRI is already available in Germany for healthcare professionals to prescribe in accordance with local guidance. In May 2012, the European Commission granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial.

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.

The results of the pivotal Phase 3 trial were published in Lancet Oncology and can be accessed at http://www.celltherapeutics.com/publications. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.

The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.pixuvri.eu.

CTI is currently accruing patients into a Phase 3 trial comparing PIXUVRI and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. PIXUVRI does not have marketing approval in the United States.


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 2,400+ scientific posters on ePosters
  • More than 3,700+ 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 TechnologyNetworks.com 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 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
Cell Therapeutics Appoints Karen Ignagni to Board of Directors
Ms. Ignagni currently serves as President and Chief Executive Officer of AHIP.
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
PIXUVRI® Receives Positive Final Appraisal Determination from NICE
PIXUVRI deemed cost effective for patients with multiply relapsed or refractory aggressive b-cell non-Hodgkin lymphoma (NHL).
Monday, January 06, 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 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
CTI Announces Results from Preclinical Study of PIXUVRI® Presented at the AACR-NCI-EORTC Meeting
Findings suggest new class of anti-cancer agents with novel mechanism for tumor cell killing.
Monday, October 21, 2013
CTI Adds Three Leaders in Blood Cancer Research and Development to SAB
Addition of Alan List, Ross Levine and Brian Druker to CTI's recently formed Scientific Advisory Board.
Monday, October 14, 2013
Market Access Granted in France for Aggressive NHL Treatment, PIXUVRI®
CT will reassess the ASMR rating for PIXUVRI within two years.
Wednesday, August 21, 2013
Daniel Von Hoff to Lead Cell Therapeutics' Scientific Advisory Board
Dr. Von Hoff will serve as Chairman of CTI's Scientific Advisory Board.
Wednesday, July 24, 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
Cell Therapeutics Announces Resignation of Chief Medical Officer
Resignation of Steven E. Benner for personal reasons.
Monday, July 01, 2013
G-BA Issues Final Assessment Report for PIXUVRI®
Pricing negotiations to begin in June.
Tuesday, May 21, 2013
Scientific News
Long Telomeres Associated with Increased Lung Cancer Risk
Genetic predisposition for long telomeres predicts increased lung adenocarcinoma risk.
Expanding the Brain
A team of researchers has identified more than 40 new “imprinted” genes, in which either the maternal or paternal copy of a gene is expressed while the other is silenced.
Identifying a Key Growth Factor in Cell Proliferation
Researchers discover that aspartate is a limiter of cell proliferation.
Study Uncovers Target for Preventing Huntington’s Disease
Scientists from Cardiff University believe that a treatment to prevent or delay the symptoms of Huntington’s disease could now be much closer, following a major breakthrough.
The Genetic Roots of Adolescent Scoliosis
Scientists at the RIKEN Center for Integrative Medical Sciences in collaboration with Keio University in Japan have discovered a gene that is linked to susceptibility of Scoliosis.
A Gene-Sequence Swap Using CRISPR to Cure Haemophilia
For the first time chromosomal defects responsible for hemophilia have been corrected in patient-specific iPSCs using CRISPR-Cas9 nucleases
New Tool Uses 'Drug Spillover' to Match Cancer Patients with Treatments
Researchers have developed a new tool that improves the ability to match drugs to disease: the Kinase Addiction Ranker (KAR) predicts what genetics are truly driving the cancer in any population of cells and chooses the best "kinase inhibitor" to silence these dangerous genetic causes of disease.
Understanding the Molecular Origin of Epigenetic Markers
Researchers at IRB Barcelona discover the molecular mechanism that determines how epigenetic markers influence gene expression.
New Tech Enables Epigenomic Analysis with a Mere 100 Cells
A new technology that will dramatically enhance investigations of epigenomes, the machinery that turns on and off genes and a very prominent field of study in diseases such as stem cell differentiation, inflammation and cancer has been developed by researchers at Virginia Tech.
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
Skyscraper Banner

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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!