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

Market Access Granted in Italy for PIXUVRI®

Published: Monday, July 08, 2013
Last Updated: Monday, July 08, 2013
Bookmark and Share
Access granted by AIFA for the aggressive non-Hodgkin lymphoma treatment.

Cell Therapeutics, Inc. (CTI) has announced that the Company has been granted market access by the Italian Medicines Agency (AIFA) 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).

Pixantrone has been classified by AIFA for use in hospitals and additional details on the pricing and reimbursement conditions for PIXUVRI in Italy will be provided coincident with the publication of the "Determina" of AIFA in the Official Gazette, which is expected to take 6 to 8 weeks.

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 2,500+ 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

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 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 OPAXIO™ Receives Orphan Drug Designation for Malignant Brain Cancer from FDA
Randomized front line trial utilizing tumor genomic profiling tests OPAXIO plus radiation therapy compared to current standard of care of radiation with temozolamide in high risk patients with glioblastoma multiforme.
Tuesday, October 09, 2012
Cell Therapeutics Appoints New Chief Medical Officer
Experienced Industry Executive, Steven E. Benner M.D., M.H.S., to lead cancer drug development.
Tuesday, June 19, 2012
CTI Completes Acquisition of Pacritinib a Highly Selective JAK2 Inhibitor
Phase 3 study in patients with myelofibrosis and low platelet counts targeted to start in Q4-2012.
Monday, June 04, 2012
CTI Enters into Agreement to Acquire Pacritinib
Reported lack of blood and platelet side effects provides attractive regulatory and commercial profile over other JAK inhibitors.
Friday, April 20, 2012
FDA's ODAC to Review Resubmitted Pixantrone NDA on February 9, 2012
ODAC will review resubmitted NDA for the treatment of relapsed or refractory aggressive NHL.
Monday, February 06, 2012
CTI Withdraws New Drug Application for Pixuvri™
The company plans to resubmit the application in 2012.
Monday, January 30, 2012
CTI Signs Long-Term Manufacturing Agreement for Pixantrone with NerPharMa
CTI plans marketing authorization application filing in Europe this year.
Wednesday, July 14, 2010
Italian Medicines Agency Approves NerPharMa to Manufacture CTI’s Drug Pixantrone in European Union
CTI is now preparing a Marketing Authorization Application in the European Union for pixantrone to treat non-Hodgkin's lymphoma.
Tuesday, June 15, 2010
Genes Identified that Enhance Tumor Cell Sensitivity to CTI's Cancer Drug Brostallicin
Systems Medicine presents data from a preclinical study that identifies potential clinical trial strategies for personalized approach to cancer treatment.
Wednesday, April 22, 2009
Scientific News
Combining Chemotherapy With Immune-Blocking Drug Could Stop Cancer Growing Back
Giving patients a drug that blocks part of the immune system from going into overdrive might help prevent cancer coming back in some people.
Researchers Pioneer Use of Capsules to Save Materials
Wax capsule delivery systems can simplify a wide range of chemistry transformations.
Photoredox Catalyst Unlocks New Pathways for Nickel Chemistry
Using a light-activated catalyst, researchers have unlocked a new pathway in nickel chemistry to construct carbon-oxygen (C-O) bonds that would be highly valuable to pharmaceutical and agrochemical industries.
Scientists Determine How Antibiotic Gains Cancer-Killing Sulfur Atoms
In a discovery with implications for future drug design scientists have shown an unprecedented mechanism for how a natural antibiotic with antitumor properties incorporates sulfur into its molecular structure, an essential ingredient of its antitumor activity.
Familiar Drugs May Block Ebola Virus Infection
A well-known class of molecules, many of which are already in use therapeutically, may be able to block the Ebola virus’s entry into cells and halt the disease in its tracks, according to researchers at the University of Illinois at Chicago.
New Extra ‘Sticky’ Microgel Could Revolutionise Bladder Cancer Treatment
Researchers have designed a new super-efficient way of delivering an anti-cancer drug which could extend and improve the quality of life for bladder cancer patients - and perhaps save lives.
Common Class of ‘Channel Blocking’ Drugs May Find a Role in Cancer Therapy
Discoveries in fruit flies prompt unusual treatment of patient with metastatic disease.
Common Medications Could Delay Brain Injury Recovery
Drugs used to treat common complaints could delay the recovery of brain injury patients according to research by University of East Anglia (UEA) and University of Aberdeen scientists, published today in Brain Injury.
Scientists Make Strides in Therapy Preventing Addiction Relapse
Single Injection of Drug Candidate Prevents Meth Relapse in Animal Models.
New Clot-Busting Treatments Target Number One Killer
Australian researchers funded by the National Heart Foundation are a step closer to a safer and more effective way to treat heart attack and stroke via nanotechnology.
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!