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Press Release

Scottish Medicines Consortium (SMC) reverses decision on Darzalex®?(daratumumab) recommending its use as monotherapy for relapsed and refractory multiple myeloma[i]

Posted on: 10 Oct 17

High Wycombe, 9 October 2017 – Janssen welcomes the Scottish Medicines Consortium (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.[ii]  This is a restricted decision for use as a fourth line treatment option. Today’s 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.[iii],[iv]


Around 5,500 new cases of myeloma are diagnosed in the UK every year,[v] with 438 new cases diagnosed in Scotland in 2014 alone.[vi] In 2015, there were over 270 deaths from myeloma in Scotland; 60 percent were men and 40 percent were 76 percent of people diagnosed with myeloma survive their disease for one year or more and 48 percent for five years or


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


Rosemarie Finley, Chief Executive, Myeloma UK, said, “This decision is great news for patients in Scotland and their loved ones. Daratumumab is an exciting and highly innovative new treatment and is a significant new “step” in the myeloma pathway for multiply relapsed myeloma patients who may be running out of treatment options. Daratumumab has been shown to have a beneficial effect on the depth of response and the length of remission; two outcomes which we know are incredibly important to patients. We are delighted at today’s news and that a vital new treatment option can now be accessed by myeloma patients in Scotland.”


Daratumumab is a monoclonal antibody which attaches specifically to a protein that is present on the surface of myeloma cells. Monoclonal antibodies mimic the antibodies that our immune system produce in response to foreign organisms (such as bacteria) that enter the body.[vii] Each group of monoclonal antibodies is made up of identical copies of one type of antibody. Monoclonal antibodies are designed to recognise and attach to specific proteins on the surface of cancer cells.6 Myeloma cells produce a protein called CD38 which is present on the cell surface.vii Daratumumab attaches to the CD38 protein found on the surface of myeloma cells, enabling the immune system to target and destroy it.vii


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. The rare and aggressive nature of multiple myeloma and the lack of effective and well-tolerated treatment options for patients who have been previously treated and become resistant to other therapies means that there is a real and urgent need for new options like daratumumab. Janssen has an inherent commitment to providing innovative and life-extending treatments to patients, therefore we are delighted to be able to provide an extra line of therapy to patients and doctors in Scotland.”

Editor's Details

Mike Wood

Last updated on: 10/10/2017

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