Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

PIXUVRI® Receives Positive Final Appraisal Determination from NICE

Published: Monday, January 06, 2014
Last Updated: Monday, January 06, 2014
Bookmark and Share
PIXUVRI deemed cost effective for patients with multiply relapsed or refractory aggressive b-cell non-Hodgkin lymphoma (NHL).

Cell Therapeutics, Inc. (CTI) has reported that the National Institute for Health and Care Excellence (NICE), the independent body responsible for driving improvement and excellence in the health and social care system in the United Kingdom (UK), has issued its Final Appraisal Determination (FAD) for PIXUVRI® (pixantrone).

The positive final draft guidance determines PIXUVRI cost effective and recommends funding the treatment as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL), which includes diffuse large B-cell lymphoma (DLBCL).

CTI estimates that there are approximately 1,600 to 1,800 people in the UK diagnosed with multiply relapsed aggressive B-cell NHL per year.

James A. Bianco, M.D., President and Chief Executive Officer of CTI stated, "The positive recommendation by NICE for the funding of PIXUVRI means that physicians in England and Wales now have access to the only approved therapy for their patients with aggressive B-cell NHL in the third- and fourth-line salvage setting."

The NICE Appraisal Committee reviewed CTI's updated data analysis showing PIXUVRI's cost effectiveness and recommended the treatment as an option for certain people with histologically confirmed aggressive B-cell NHL who have previously received rituximab and are receiving PIXUVRI as a third- or fourth-line treatment.

The FAD further recommends the prescription of PIXUVRI for as long as CTI makes the Patient Access Scheme (PAS) available. The PAS is a confidential pricing and access agreement with the UK's Department of Health.

The FAD forms the basis of the final guidance to the NHS in England and Wales and is expected to be published in February 2014. Once the final guidance is published, the NHS must fully implement it within 90 days. CTI expects to officially launch PIXUVRI in England and Wales in early spring, when the FAD has been largely implemented.

Professor John Radford, a lymphoma expert at The University of Manchester and The Christie NHS Foundation Trust in Manchester - both part of the Manchester Cancer Research Centre said, "DLBCL is the most common type of aggressive NHL and despite undoubted progress over the last 10 years resulting from the introduction of better first-line therapy, the disease still recurs in some patients. The recent recommendation by NICE for the funding of PIXUVRI provides an additional treatment option for these patients and is a welcome development."

Professor Finbarr E. Cotter, Professor of Haematology and Chair of Experimental Haematology, Centre for Haemato-Oncology, Barts Cancer Institute, and representative for the British Society for Haematology (BSH) commented, "The availability of PIXUVRI means physicians will be able to extend an approved salvage regimen to those patients that fail second- or third-line therapy. The data from the pivotal EXTEND Phase 3 trial of PIXUVRI clearly indicate that this drug is effective in heavily pretreated patients with relapsed or refractory aggressive NHL."


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 2,500+ 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 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
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
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
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
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
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
Scientific News
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
Immunotherapy Agent Benefits Patients with Drug-Resistant Multiple Myeloma in First Human Trial
Daratumumab proved generally safe in patients, even at the highest doses.
Low-level Arsenic Exposure Before Birth Associated with Early Puberty in Female Mice
Study examine whether low-dose arsenic exposure could have similar health outcomes in humans.
Inciting an Immune Attack On Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Cellular Contamination Pathway for Heavy Elements Identified
Berkeley Lab scientists find that an iron-binding protein can transport actinides into cells.
Intensity of Desert Storms May Affect Ocean Phytoplankton
MIT study finds phytoplankton are extremely sensitive to changing levels of desert dust.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Scroll Up
Scroll Down
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!