Following the referral of plitidepsin in combination with dexamethasone for treating relapsed or refractory multiple myeloma to NICE by the Department for Health and Social Care, the company have now confirmed that following a re-examination by the Committee for Medicinal Products for Human Use (CHMP), at the company’s request, a further refusal of the marketing authorisation was given on 22 March 2018. Therefore, the planned appraisal of plitidepsin in this indication has been suspended on the technology appraisals work programme.
 
Status Suspended
Decision Selected
Process STA pre-2018
ID number 1081

Project Team

Project lead Jeremy Powell

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
20 April 2018 Suspended. Following the referral of plitidepsin in combination with dexamethasone for treating relapsed or refractory multiple myeloma to NICE by the Department for Health and Social Care, the company have now confirmed that following a re-examination by the Committee for Medicinal Products for Human Use (CHMP), at the company’s request, a further refusal of the marketing authorisation was given on 22 March 2018. Therefore, the planned appraisal of plitidepsin in this indication has been suspended on the technology appraisals work programme.
09 June 2017 Following on from advice received from the company this appraisal has been rescheduled. Therefore, we now anticipate that the appraisal will begin during mid December 2017 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately late February 2018.
20 April 2017 - 19 May 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
05 December 2016 Referral
05 December 2016 In progress. Topic referred

For further information on our processes and methods, please see our CHTE processes and methods manual