For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. 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.
 
Status Suspended
Technology type Medicine
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process TA
ID number 5096

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Timeline

Key events during the development of the guidance:

Date Update
17 June 2024 Suspended. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. 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.
12 October 2023 Please note that 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 November 2024 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-February 2025.
27 April 2023 Please note that 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 early March 2024 when we will write to stakeholders about how they can get involved. The deadline for submissions is expected in approximately mid-May 2024.
05 December 2022 As you will be aware, the Department for Health & Social Care has asked NICE to conduct an appraisal of Navitoclax with ruxolitinib for treating myelofibrosis when stem cell transplant is unsuitable. Please note that 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 in early September 2023 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early November 2023.
04 May 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
30 March 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
30 March 2022 Topic selection

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