Please be advised that the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of guadecitabine for untreated acute myeloid leukaemia. However, the company have advised that the ASTRAL-1 study did not meet the co-primary endpoints of complete response (CR) rate or overall survival (OS). 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 as and when the situation changes.
 
Status Suspended
Process TAG

Timeline

Key events during the development of the guidance:

Date Update
16 August 2018 Please be advised that the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of guadecitabine for untreated acute myeloid leukaemia. However, the company have advised that the ASTRAL-1 study did not meet the co-primary endpoints of complete response (CR) rate or overall survival (OS). 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 as and when the situation changes.
16 August 2018 Suspended, Please be advised that the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of guadecitabine for untreated acute myeloid leukaemia. However, the company have advised that the ASTRAL-1 study did not meet the co-primary endpoints of complete response (CR) rate or overall survival (OS). 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 as and when the situation changes.
19 September 2016 In progress, Topic referred

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