Following on from information provided to NICE by the company in November 2015, the appraisal of Ofatumumab for the maintenance treatment of relapsed chronic lymphocytic leukaemia [ID732] 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 | 732 |
| Referral date | 01 July 2014 |
Provisional Schedule
| Closing date for invited submissions / evidence submission: | TBC |
| 1st appraisal committee meeting: | TBC |
Email enquiries
- If you have any queries please email scheduling@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 23 January 2023 | Discontinued. Following on from information provided to NICE by the company in November 2015, the appraisal of Ofatumumab for the maintenance treatment of relapsed chronic lymphocytic leukaemia [ID732] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued. |
| 03 February 2017 | As you will be aware, the Department of Health has asked us to conduct a Single Technology Appraisal of ofatumumab within its licensed indication for the maintenance treatment of relapsed chronic lymphocytic leukaemia. However, the company have advised that they will not be pursuing a licensing application for ofatumumab from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal on its work programme. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes. |
| 06 September 2016 | This appraisal remains suspended following an update from the company (Novartis). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has decided not to approve ofatumumab for the maintenance treatment of relapsed chronic lymphocytic leukaemia. NICE will continue to monitor for any developments and will provide an update when necessary. |
| 02 November 2015 | Suspended. This appraisal has formally started now, in line with the anticipated regulatory timelines. However, the manufacturer of ofatumumab has informed us that they will not provide an evidence submission for this appraisal. NICE has therefore suspended this appraisal and we will provide further updates when they are available. |
| 30 December 2014 | Please note that following on from advice received from the company this appraisal has been rescheduled.Therefore, we now anticipate that the appraisal will begin during late October 2015 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early January 2016. |
For further information on our processes and methods, please see our CHTE processes and methods manual