Lenalidomide for the maintenance treatment of multiple myeloma after autologous stem cell transplantation
 
Status In progress
Process STA pre-2018
ID number 475
Referral date 01 July 2011
Topic area
  • Cancer

Project Team

Project lead Jeremy Powell

Email enquiries

Consultees

Companies sponsors Celgene (lenalidomide)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Myeloma UK
Professional groups Association of Cancer Physicians
  British Committee for Standards in Haematology
  British Society for Haematology
  Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  UK Myeloma Forum

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord (Lenalidomide Accord) (not participating)
  Amgen (carfilzomib) (not participating)
  Aspen (melphalan) (not participating)
  Aspire Pharma (Bortezomib) (not participating)
  Celgene (thalidomide)
  Janssen (bortezomib)
  Sun Pharma (melphalan) (not participating)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare Products Regulatory Agency
  Welsh Health Specialised Services
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
08 September 2020 - 29 September 2020 Appraisal consultation: 1
13 August 2020 Committee meeting: 1
12 December 2019 Invitation to participate
08 July 2019 In progress. Following on from advice received from Celgene, the timelines for this appraisal have been revised and the appraisal is now anticipated to formally begin in early December 2019.
16 April 2019 Suspended, NICE have been in contact with Celgene about a revised submission date and will be in a position next month to provide an update about rescheduling the Single Technology Appraisal for lenalidomide as maintenance treatment of multiple myeloma after autologous stem cell transplantation (ID475).
08 December 2016 Suspended. NICE have agreed to reschedule the Single Technology Appraisal for lenalidomide as maintenance treatment of multiple myeloma after autologous stem cell transplantation (ID475). Celgene have advised NICE that they do not yet have access to the required data and therefore their submission is still in development. We will provide an update once we can confirm rescheduling dates
10 August 2016 In progress. We have recently received advice from the company that they have now re-submitted their regulatory dossier to the EMA and this appraisal has therefore been rescheduled back into the work programme.
10 July 2012 The Manufacturer has informed NICE that it has withdrawn its application for the new licence indications for Lenalidomide and that it now plans to re-submit with more mature data. Therefore, we are suspending this appraisal whilst we consider the next steps and the Appraisal Committee meeting scheduled for Wednesday 11 October has been cancelled.
12 January 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 early May 2012 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early July 2012.

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