The Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for masitinib for treating systematic mastocytosis. Consequently the first appraisal committee discussion of this topic, has been cancelled. We will continue to monitor any developments and will update interested parties if the situation changes.
 
Status Suspended
Process STA
ID number 781

Project Team

Project lead Thomas Feist

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
18 September 2017 Suspended, The Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for masitinib for treating systematic mastocytosis. Consequently the first appraisal committee discussion of this topic, has been cancelled. We will continue to monitor any developments and will update interested parties if the situation changes.
12 February 2016 Following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during late August 2016 when. The deadline for submissions is expected in approximately late October 2016.
27 November 2015 Draft scope documents
04 November 2015 Referral

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