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Archived: daratumumab (Darzalex)

Advice

following a full submission considered under the end of life and orphan process

daratumumab (Darzalex®): is not recommended for use within NHS Scotland.

Indication under review: as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

In a pooled analysis of patients in a phase I/II and a phase II study, with heavily pre-treated multiple myeloma, who received the licensed dosing schedule of daratumumab, there was an overall response rate of 31%.

The submitting company’s justification of the treatment’s costs in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic and clinical analysis to gain acceptance by SMC.

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

Drug Details

Drug Name: daratumumab (Darzalex)
SMC Drug ID: 1205/17
Manufacturer: Janssen-Cilag Ltd
Indication: As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
BNF Category:
Sub Category: 8.2 Drugs affecting the immune response
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 16 January 2017

Current Advice

Resubmission 9 October 2017

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