SMC reverses decision on Darzalex®▼(daratumumab)

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Janssen has welcomed the Scottish Medicines Consortium’s (SMC) decision recommending Darzalex®▼(daratumumab) for restricted use 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.

The decision follows previous guidance from the SMC and the National Institute of Clinical Excellence (NICE) which did not recommend the use of daratumumab in this indication. It is a restricted decision for use as a fourth line treatment option. 

The SMC recommendation is based on the results of a Phase 2 part-randomised study (MMY2002) and a Phase 1/2 dose-escalation study (GEN501) conducted in adults with multiple myeloma and an Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.

The SMC also considered the benefits of Janssen’s Patient Access Scheme (PAS) which supported the cost-effectiveness of daratumumab.

Around 5500 new cases of myeloma are diagnosed in the UK every year, with 438 new cases diagnosed in Scotland in 2014 alone.

In 2015, there were over 270 deaths from myeloma in Scotland; 60% were men and 40% were women.76% of people diagnosed with myeloma survive their disease for one year or more, while 48% survive for five years or more.

Daratumumab is a monoclonal antibody which attaches specifically to a protein that is present on the surface of myeloma cells. Myeloma cells produce a protein called CD38 which is present on the cell surface. Daratumumab attaches to the CD38 protein found on the surface of myeloma cells, enabling the immune system to target and destroy it.

Rosemarie Finley, Chief Executive, Myeloma UK, said: “We are delighted at today’s news and that a vital new treatment option can now be accessed by myeloma patients in Scotland.”

Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen UK, said, “Janssen welcomes the SMC’s positive recommendation for daratumumab as a monotherapy for relapsed or refractory multiple myeloma and we hope that NICE will follow suit.”