Title: Daratumumab monotherapy for treating relapsed and refractory multiple myeloma (CDF review of TA510) [ID3881]
Funder: Department of Health and Social Care

Abstract: Multiple myeloma is a form of cancer that arises from plasma cells (a type of white blood cell) in the bone marrow. Myeloma cells produce large quantities of an abnormal antibody, known as paraprotein. Unlike normal antibodies, paraprotein has no useful function and lacks the capacity to fight infection. Myeloma cells supress the development of normal blood cells that are responsible for fighting infection (white blood cells), carrying oxygen around the body (red blood cells) and blood clotting (platelets). The term multiple myeloma refers to the presence of more than one site of affected bone at the time of diagnosis. People with multiple myeloma can experience bone pain, bone fractures, tiredness (due to anaemia), infections, hypercalcaemia (too much calcium in the blood) and kidney problems._x000D_ _x000D_ In 2013, 4,703 people were diagnosed with multiple myeloma in England. [1] Forty-three percent of people diagnosed are aged 75 years and over. [1] Multiple myeloma is more common in men than in women and the incidence is also reported to be higher in people of African family origin. [1] The 5-year survival rate for adults with multiple myeloma in England is estimated to be 47%. [2]_x000D_ _x000D_ The main aims of therapy are to prolong survival and maintain a good quality of life by controlling the disease and relieving symptoms. Following initial treatment, subsequent therapy is influenced by previous treatment and response to it, duration of remission, comorbidities and patient preference. NICE technology appraisal guidance 129 recommends bortezomib monotherapy as an option for treating progressive multiple myeloma in people who are at first relapse having received 1 prior therapy and who have undergone, or are unsuitable for bone marrow transplantation. NICE technology appraisal guidance 171 recommends lenalidomide in combination with dexamethasone as a treatment option for people with multiple myeloma who have received at least 2 prior therapies. NICE technology appraisal guidance 380 recommends panobinostat in combination with bortezomib and dexamethasone as an option for treating multiple myeloma in adults with relapsed and/or refractory multiple myeloma who have received at least 2 prior regimens including bortezomib and an immunomodulatory agent. NICE technology appraisal guidance 427 recommends pomalidomide plus low-dose dexamethasone as a treatment option for adults who have had at least 3 previous treatments including both lenalidomide and bortezomib. For people who have had at least 3 prior therapies, treatment options include bendamustine (available through the Cancer Drugs Fund) or combination chemotherapy regimens (for example, alkylating agents such as melphalan and cyclophosphamide). Other subsequent treatment options may include repeating high-dose chemotherapy or chemotherapy with alkylating agents and anthracyclines, thalidomide and corticosteroids. Daratumumab monotherapy is recommended for use in the Cancer Drugs Fund for adults with relapsed and refractory multiple myeloma that has previously been treated with 3 treatments including a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy (NICE TA510)._x000D_ _x000D_ References_x000D_ 1. Cancer Research UK (2013) Multiple myeloma incidence statistics. Accessed February 2016._x000D_ 2. Cancer Research UK (2011) Multiple myeloma survival statistics. Accessed February 2016

Lay abstract: To appraise the clinical and cost effectiveness of daratumumab within its marketing authorisation for treating relapsed and refractory multiple myeloma.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: CANCER AND NEOPLASMS