Please be advised that the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of pembrolizumab with epacadostat for untreated malignant melanoma. However, the company have advised that the pivotal study did not meet the primary endpoint of improving progression-free survival in the overall population and they will not be seeking regulatory approval from the European Medicines Authority for this indication at this time Therefore, NICE has decided to suspend this appraisal from its work programme. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties if the situation changes.
 
Status Suspended
Process TAG

Timeline

Key events during the development of the guidance:

Date Update
11 May 2018 Suspended, Please be advised that the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of pembrolizumab with epacadostat for untreated malignant melanoma. However, the company have advised that the pivotal study did not meet the primary endpoint of improving progression-free survival in the overall population and they will not be seeking regulatory approval from the European Medicines Authority for this indication at this time Therefore, NICE has decided to suspend this appraisal from its work programme. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties if the situation changes.

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