Patients in Europe with multiple myeloma are a step closer to a new treatment after Janssen filed its investigational monoclonal antibody daratumumab for approval.
The disease is the UK’s second most common form of bone marrow cancer, with around 4,800 diagnosed every year.
Janssen is seeking a green light to market the drug for the treatment of relapsed and refractory forms, targeting a group of patients with a particularly poor prognosis; those refractory to both proteasome inhibitors or immunomodulatory agents have an estimated median overall survival of just nine months.
Daratumumab, which carries orphan drug status in both the EU and US, works by binding to a signalling molecule found on the surface of multiple myeloma cells called CD38 to trigger the patient’s own immune system to attack the cancer cells.
One clinical trial (MMY2002) of the drug showed a response rate of 29% in heavily pre-treated patients, with a “tolerable safety profile”.