The National Institute for Health and Care Excellence (NICE) has published draft guidance stating that it does not recommend Janssen’s Darzalex (daratumumab) plus bortezomib, thalidomide and dexamethasone, as a treatment option for untreated multiple myeloma in adults who are eligible for an autologous stem cell transplant.

Currently, most individuals with this condition receive a combination of bortezomib plus thalidomide and dexamethasone (VTd) prior to their stem cell transplant.

Clinical trial evidence suggests that people treated with Darzalex plus bortezomib, thalidomide and dexamethasone live longer and have more time before their tumour progresses, compared to individuals treated with bortezomib plus VTd alone.

However, the UK regulatory body expressed concerns around the long-term effectiveness of the combination treatment, as well as its cost-effectiveness, which is ‘most likely’ higher than what NICE normally considers an acceptable use of NHS resources.

In 2020, the European Commission (EC) granted Darzalex combined with VTd a marketing authorisation for newly diagnosed, transplant eligible patients with multiple myeloma.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells. In Europe, more than 48,200 people were diagnosed with the disease in 2018, with more than 30,800 deaths related to the disease.