Pralatrexate for the treatment of relapsed or refractory peripheral T-cell lymphoma
 
Status Suspended
Process STA
Referral date 01 September 2010
Topic area
  • Cancer
Description

Scoped within Batch 13

Provisional Schedule

Closing date for invited submissions / evidence submission: 18 January 2012
1st appraisal committee meeting: TBC
2nd appraisal committee meeting TBC

Project Team

Communications manager: Alice Law
Executive Lead: Peter Littlejohns
Project manager: Rebecca Pye
Technical Lead: Pall Jonsson

Consultees

Manufacturers/sponsors Allos Therapeutic (pralatrexate)
Others Department of Health
  NHS Camden
  NHS Middlesbrough
  Welsh Assembly Government
Patient/carer groups Afiya Trust
  African Caribbean Leukaemia Trust (ACLT)
  Anthony Nolan Bone Marrow Trust
  Black Health Agency
  CANCERactive
  Cancer Black Care
  Cancer 52
  Counsel and Care
  Equalities National Council
  Helen Rollason Heal Cancer Charity
  Leukaemia CARE
  Leukaemia Society (UK)
  Lymphoma Association
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie Cancer Care
  Muslim Council of Britain
  Muslim Health Network
  Rarer Cancers Foundation
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Sue Ryder Care
  Tenovus
Professional groups Association of Cancer Physicians
  British Association for Services to the Elderly
  British Committee for Standards in Haematology
  British Geriatrics Society
  British Psychosocial Oncology Society
  British Society for Haematology
  Cancer Networks Pharmacists Forum
  Cancer Research UK
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  United Kingdom Clinical Pharmacy Association
  United Kingdom Oncology Nursing Society

Commentators

Associated guideline groups National Collaborating Centre for Cancer
Associated public health groups None
Comparator manufacturers Actavis UK (epirubicin, fludarabine, gemcitabine, prednisolone)
  Alliance Pharmaceuticals (prednisolone)
  Amdipharm (prednisolone)
  Auden McKenzie (Pharma Division) (dexamethasone)
  Baxter (cyclophosphamide, ifosfamide)
  Bristol-Myers Squibb (carboplatin, cisplatin, etoposide)
  Chemidex pharma (dexamethasone)
  Eli Lilly and Company (gemcitabine)
  Genzyme Therapeutics (fludarabine)
  Goldshield Critical Care (cisplatin)
  Hameln Pharmaceuticals (epirubicin)
  Hospira UK (carboplatin, cisplatin, cytarabine, epirubicin, etoposide, fludarabine, gemcitabine)
  Medac UK (epirubicin, etoposide, gemcitabine, lomustine)
  Merck Sharp & Dohme (dexamethasone)
  Mylan (epirubicin, gemcitabine)
  Pfizer (cisplatin, cyclophosphamide, cytarabine, epirubicin, methylprednisolone)
  Rosemont Pharmaceuticals (dexamethasone)
  Sandoz (carboplatin, cisplatin, epirubicin, fludarabine, gemcitabine)
  Sigma Pharmaceuticals (methylprednisolone)
  Sun Pharmaceuticals UK (carboplatin, gemcitabine)
  Teva UK (carboplatin, cisplatin, epirubicin, etoposide, fludarabine, gemcitabine)
  Wockhardt UK (carboplatin, cisplatin, epirubicin, fludarabine, gemcitabine)
Evidence Review Group British Medical Journal (BMJ)
  National Institute for Health Research Health Technology Assessment Programme
General Board of Community Health Councils in Wales
  British National Formulary
  Commissioning Support Appraisals Service
  Department of Health,Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  NHS Alliance
  NHS Commercial Medicines Unit
  NHS Confederation
  Public Health Wales NHS Trust
  Scottish Medicines Consortium
Relevant research groups British National Lymphoma Investigation
  Elimination of Leukaemia Fund
  Institute of Cancer Research
  Leukaemia Busters
  Leukaemia & Lymphoma Research
  MRC Clinical Trials Unit
  National Cancer Research Institute
  National Cancer Research Network
  National Institute for Health Research
  Policy Research Institute on Ageing and Ethnicity
  Research Institute of the Care of Older People

Timeline

Key events during the development of the guidance:

Date Update
17 February 2012 Following an update on the regulatory status of the technology which has received a negative CHMP opinion, the 25 April 2012 committee meeting discussion for this appraisal has been cancelled. We are monitoring this situation and will provide an update as soon as possible.
1 December 2011 We have received the latest regulatory timings for pralatrexate from the manufacturer, Allos Therapeutics, and are now able to update our timelines for the above appraisal. The first committee meeting will be held on 25 April 2012.
13 July 2011 Following an update from the manufacturer, Allos Therapeutics, on the regulatory timings for pralatrexate the 27 September 2011 committee meeting discussion for the above appraisal has been cancelled.

We will update this page with the new timings as soon as possible.

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance