The appraisal of pembrolizumab with chemotherapy for neoadjuvant and adjuvant treatment of untreated locally advanced non-metastatic triple negative breast cancer has been paused following the submissions being received in late-November 2021.
Due to the volume of topics within the NICE work programme, NICE is giving priority scheduling to new active substances so guidance can be published within 3 months of the topic receiving MA. This is a KPI which is set by the Department of Health. This KPI does not apply for licence extensions. Licence extensions where possible are being scheduled to allow first publication (FAD or ACD) to be published within 6 months of the GB marketing authorisation being received. It is acknowledged that this may not always be achievable.
Therefore, we anticipate that the appraisal will restart in mid-March 2022 when the submissions are sent over to the Evidence Review Group (ERG) and will be discussed at committee in mid- September 2022.