Advice

following a full submission assessed under the orphan medicine process:

daratumumab (Darzalex®) is accepted for use within NHSScotland.

Indication under review: in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

In a phase III study, daratumumab, in combination with lenalidomide and dexamethasone, improved progression-free survival compared with lenalidomide plus dexamethasone in patients with newly diagnosed multiple myeloma ineligible for ASCT.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

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Medicine details

Medicine name:
daratumumab (Darzalex)
SMC ID:
SMC2536
Indication:

Daratumumab in combination with lenalidomide and dexamethasone (DLd) is licensed for use for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT).

Pharmaceutical company
Janssen-Cilag Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Accepted
Date advice published
11 September 2023