Romidepsin for the treatment of relapsed or refractory peripheral T-cell lymphoma
 
Status Suspended
Process STA
Referral date 01 November 2011
Topic area
  • Cancer
Description

Scoped as part of Batch 20

Provisional Schedule

Closing date for invited submissions / evidence submission: 22 June 2012
1st appraisal committee meeting: TBC

Project Team

Communications manager: Laura Gibson
Executive Lead: TBC
Project manager: Rebecca Pye
Technical Lead: TBC

Consultees

Manufacturers/sponsors Celgene (romidepsin)
Others Department of Health
  Leicestershire PCT cluster
  South East London PCT cluster
  Welsh Government
Patient/carer groups Lymphoma Association
  Rarer Cancers Foundation
Professional groups British Society for Haematology
  Cancer Research UK
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians

Commentators

Associated Guideline Groups National Collaborating Centre for Cancer
Associated Public Health Groups None
Comparator manufacturers Actavis UK (epirubicin, fludarabine, gemcitabine, prednisolone) Confidentiality agreement not signed, not participating
  Alliance Pharmaceuticals (prednisolone) Confidentiality agreement not signed, not participating
  Amdipharm (prednisolone) Confidentiality agreement not signed, not participating
  Auden McKenzie (Pharma Division) (dexamethasone)Confidentiality agreement not signed, not participating
  Baxter (cyclophosphamide, ifosfamide) Confidentiality agreement not signed, not participating
  Bristol-Myers Squibb (carboplatin, cisplatin, etoposide)Confidentiality agreement not signed, not participating
  Eli Lilly and Company (gemcitabine) Confidentiality agreement not signed, not participating
  Essential Generics (dexamethasone) Confidentiality agreement not signed, not participating
  Genzyme Therapeutics (fludarabine) Confidentiality agreement not signed, not participating
  Goldshield Critical Care (cisplatin) Confidentiality agreement not signed, not participating
  Hameln Pharmaceuticals (epirubicin) Confidentiality agreement not signed, not participating
  Hospira UK (carboplatin, cisplatin, cytarabine, epirubicin, etoposide, fludarabine, gemcitabine) Confidentiality agreement not signed, not participating
  Medac UK (epirubicin, etoposide, gemcitabine, lomustine) Confidentiality agreement not signed, not participating
  Merck Sharp & Dohme (dexamethasone) Confidentiality agreement not signed, not participating
  Mylan (epirubicin, gemcitabine) Confidentiality agreement not signed, not participating
  Pfizer (cisplatin, cyclophosphamide, cytarabine, epirubicin, methylprednisolone) Confidentiality agreement not signed, not participating
  Rosemont Pharmaceuticals (dexamethasone) Confidentiality agreement not signed, not participating
  Sandoz (carboplatin, cisplatin, epirubicin, fludarabine, gemcitabine) Confidentiality agreement not signed, not participating
  Sigma Pharmaceuticals (methylprednisolone) Confidentiality agreement not signed, not participating
  Sun Pharmaceuticals UK (carboplatin, gemcitabine) Confidentiality agreement not signed, not participating
  Teva UK (carboplatin, cisplatin, epirubicin, etoposide, Confidentiality agreement not signed, not participating
  Wockhardt UK (carboplatin, cisplatin, epirubicin, fludarabine, gemcitabine) Confidentiality agreement not signed, not participating
Evidence Review Group NHS Centre for Reviews and Dissemination and Centre for Health Economics - York
  National Institute for Health Research Health Technology Assessment Programme
General Commissioning Support Appraisals Service
  Department of Health,Social Services and Public Safety for Northern Ireland
  Health Improvement Scotland
Relevant research groups None

Timeline

Key events during the development of the guidance:

Date Update
23 November 2012

Following an update on the regulatory status of this technology which has received a negative CHMP opinion, this appraisal remains suspended whilst we consider the next steps.

10 July 2012

The manufacturer of romidepsin has informed NICE that they will not provide an evidence submission for this appraisal. NICE has therefore suspended this appraisal.

22 February 2012

Following on from advice received from the manufacturer, this appraisal has now been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during late April 2012 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately late June 2012.


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