NICE says 'yes' to Darzalex for relapsed and refractory MM

UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Darzalex (daratumumab) monotherapy for adult patients with relapsed and refractory multiple myeloma that has previously been treated with three therapies, including a proteasome inhibitor and an immunomodulator, and who have demonstrated disease progression on the last therapy.

The decision was welcomed by Janssen, a pharmaceutical unit of US healthcare giant Johnson & Johnson (NYSE: JNJ), for whom it is the best-selling drug with 2021 global sales of $6.02 billion. Darzalex was developed by Danish cancer specialist Genmab (OMX: GEN) and out-licensed to J&J.

The positive Final Appraisal Document (FAD) follows over four years of continued use of daratumumab monotherapy in England for treating relapsed and refractory multiple myeloma, after it was initially recommended for use through the Cancer Drugs Fund (CDF) in 2018. Since its availability via the CDF, real-world evidence has been collected via Systemic Anti-Cancer Therapy (SACT) data to provide additional certainties of benefit. This was supplemented with final analyses from the Phase II registrational study MMY2002, after a median follow-up of 36.7 months, to inform the reappraisal at the end of the CDF funding period.