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Soft tissue sarcoma - trabectedin

Trabectedin for the treatment of advanced soft tissue sarcoma

Status:	History
Expected date of issue:	February 2010
Referral date:	July 2008
Wave:	18
Process:	STA
Topic area: Cancer

Project team | Schedule | Stakeholders | Project history | Key documents

 

NICE project team

Executive Lead:	Gillian Leng
Technical Lead:	Whitney Miller
Communications manager:	Laura Gibson
Project manager:	Jeremy Powell
Evidence review group:	School of Health & Related Research Sheffield (ScHARR)

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Provisional schedule

Closing date for invited submissions / evidence submission:	26 November 2008
1st appraisal committee meeting:	02 June 2009
2nd appraisal committee meeting	04 August 2009
3rd appraisal committee meeting:	03 November 2009

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Consultees and commentators

Commentators Consultators (no right of appeal) Manufacturers/ Sponsors Pharma Mar (trabectedin)   Patient / Carer Groups Rarer Cancers Forum Sarcoma UK   Professional Groups British Sarcoma Group Cancer Research UK Royal College of Nursing Royal College of Pathologists Royal College of Physicians – Medical Oncology Joint Special Committee Royal College of Radiologists   Others Department of Health Welsh Assembly Government General Department of Health, Social Services and Public Safety for Northern Ireland NHS Quality Improvement Scotland   Comparator Manufacturers None   Relevant research groups MRC Clinical Trials Unit   Evidence Review Group School of Health & Related Research Sheffield (ScHARR) National Institute for Health Research (NIHR) Health Technology Assessment Programme (HTA Programme)   Associated Guideline Groups National Collaborating Centre for Cancer   Associated Public Health Groups None

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Project history

Date  Update 11 December 2008 An extension to the timelines for submission of evidence in this appraisal has been granted on request of the marketing authorisation holder for Trabectedin to allow them to meet the full requirements of the STA process. The appraisal will now be discussed at a committee meeting on 2 June 2009 and the earliest anticipated guidance publication will be in October 2009. 7 October 2009 The manufacturer has submitted a Patient Access Scheme. This will be critiqued by the ERG and considered by the Committee on 3 November 2009

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Key documents

Soft tissue sarcoma - trabectedin: final appraisal determination 21 December 2009 Soft tissue sarcoma - trabectedin: update to consultees and commentators 15 October 2009 Soft tissue sarcoma - trabectedin: appraisal consultation 29 June 2009 Soft tissue sarcoma - trabectedin: letter to consultees and commentators about extension to timelines 11 December 2008 Soft tissue sarcoma - trabectedin: final scope 02 October 2008 Soft tissue sarcoma - trabectedin: response to consultee and commentator comments on the draft scope 02 October 2008 Soft tissue sarcoma - trabectedin: response to consultee and commentator comments on the provisional matrix 02 October 2008

This page was last updated: 30 March 2010