- NHL Treatment
- Hodgkin's Treatment
- Clinical Trials
- Monoclonal Antibodies
Biopharmaceutical company Cell Therapeutics, Inc. has announced that the National Institute for Health and Care Excellence (NICE), a non-departmental public body of the Department of Health in the United Kingdom (UK), has issued second draft guidance on Pixurvi (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma (aggressive B-cell NHL).
An independent Appraisal Committee for NICE got together on Sept. 11, 2013 to weigh the cost effectiveness of pixantrone using Cell Therapeutics' initial patient access scheme that was approved by the Department of Health in July of 2013.
This committee concluded that the patient access scheme failed to overcome the "uncertainties in the evidence for pixantrone's clinical effectiveness" and is requesting that consultees, including CTI, healthcare professionals and members of the public, not comment on the draft guidance via the NICE website. A final Appraisal Committee meeting is scheduled for the middle of November, and at this time CTI is expected to learn whether NICE will consider a so-called enhanced patient access scheme in the UK.
The European Commission (EC) granted conditional marketing authorization in the European Union for pixantrone in May of 2012 as a monotherapy for adult patients with multiply relapsed or refractory aggressive B-cell NHL. Approval was based on the results of the EXTEND (PIX301) pivotal randomized Phase III clinical trial. The drug has therefore been available to patients in eight European countries for more than a year.