Evidence-based recommendations on olaratumab (Lartruvo) plus doxorubicin for advanced soft tissue sarcoma in adults.
January 2019: The European Medicines Agency (EMA) has issued a press release following preliminary results from the ANNOUNCE study. ANNOUNCE is a phase 3 study of olaratumab with doxorubicin in people with advanced or metastatic soft tissue sarcoma. Early results show that olaratumab is not more effective at prolonging the lives of people compared with doxorubicin alone (a standard care treatment). The EMA have advised that no new people should start treatment with olaratumab and NHS England have confirmed that the Cancer Drugs Fund will not fund any new people, while full results from the study are awaited. People taking olaratumab and appearing to benefit from it, should talk to their doctor about their continued treatment or other treatment options. Further updates will be provided as the situation progresses.
Is this guidance up to date?
Next review: More evidence on olaratumumab is being collected, until December 2020. After this NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.
Guidance development process
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.