The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of Darzalex®(daratumumab) monotherapy within the Cancer Drugs Fund (CDF) as an option for treating relapsed and refractory multiple myeloma in adults whose prior therapy included a proteasome inhibitor and an immunomodulatory, and whose disease progressed on the last therapy. NICE recommends that patients who have already had three previous therapies and meet the conditions in the managed access agreement are eligible for daratumumab monotherapy.
The Final Appraisal Determination (FAD) by NICE follows previous guidance which did not recommend the use of daratumumab in this indication. NICE recognised that few NICE-recommended treatment options are currently available for myeloma patients and there remains a need for effective, well-tolerated treatment options for those whose disease has progressed after three previous therapies. Granting access to daratumumab within the CDF provides such an option and allows for the collection of additional clinical evidence within the NHS.
Rosemarie Finley, Chief Executive Myeloma UK, said: “This is excellent news for myeloma patients and their families. There is still significant unmet need in this patient population so approval of this exciting and innovative new therapy is extremely welcome. The ability to now use daratumumab with its known side effect profile in monotherapy might help patients that suffer under the cumulative side effects of previous treatments. We commend Janssen, NICE and NHS England for their continued efforts in working together to secure access for patients.”
Around 5,500 new cases of myeloma are diagnosed in the UK every year. In 2014, there were over 2,900 deaths from myeloma in the UK; 55 percent were men and 45 percent were women. 77 percent of people diagnosed with myeloma in England and Wales survive their disease for one year or more, while 47% survive for five years or more.
Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen-Cilag Limited, said, “Janssen welcomes NICE’s positive recommendation for daratumumab monotherapy for relapsed and refractory multiple myeloma; particularly after it was previously recommended in Scotland for the same patient group. 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 there has been 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 across the UK.”
The NICE FAD 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.
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.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. Daratumumab attaches to the CD38 protein found on the surface of myeloma cells, enabling the immune system to target and destroy it.
