Following on from information provided to NICE by the company in August 2018, the appraisal of Guadecitabine for untreated acute myeloid leukaemia [ID1411] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
 
Status Discontinued
Technology type Medicine
Decision Selected
Process TA
ID number 1411

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Timeline

Key events during the development of the guidance:

Date Update
31 October 2022 Following on from information provided to NICE by the company in August 2018, the appraisal of Guadecitabine for untreated acute myeloid leukaemia [ID1411] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
31 October 2022 Discontinued. Following on from information provided to NICE by the company in August 2018, the appraisal of Guadecitabine for untreated acute myeloid leukaemia [ID1411] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
30 March 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of guadecitabine for untreated acute myeloid leukaemia [ID1411]. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the European Medicines Agency for this indication at this time, this is as a result of the ASTRAL-1 study not meeting it’s co-primary endpoint. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
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

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