On September 25, 2015 Janssen-Cilag International NV reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its request for an accelerated assessment of the daratumumab Marketing Authorisation Application (MAA) (Press release, Johnson & Johnson, SEP 25, 2015, View Source [SID:1234507552]). This acceptance follows the earlier regulatory submission of a MAA which seeks authorisation of daratumumab as a single agent for the treatment of patients with relapsed and refractory multiple myeloma and is currently pending validation by the EMA.
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The CHMP grants accelerated assessment when a medicinal product is expected to be of major public health interest particularly from the point of view of therapeutic innovation.
Daratumumab is an investigational, human anti-CD38 monoclonal antibody that works by binding to CD38, a signalling molecule found on the surface of multiple myeloma cells.1,2,3,4 In doing so, daratumumab triggers the patient’s own immune system to attack the cancer cells, resulting in rapid tumour cell death through multiple immune-mediated and other mechanisms of action.5
The MAA includes data from the Phase 2 MMY2002 (SIRIUS) monotherapy study, presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper),6 and data from the Phase 1/2 GEN501 monotherapy study, recently published in The New England Journal of Medicine,7 and data from three additional supportive studies.
"Janssen is pleased with the CHMP’s acceptance of an accelerated regulatory review timeline for daratumumab, which reflects the high unmet need for new treatment options for patients with multiple myeloma, currently an incurable disease," said Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa. "We continue to work closely with European health authorities to make daratumumab available to these patients as soon as possible."
In July 2013 daratumumab was granted Orphan Drug Status by the EMA for the treatment of plasma cell myeloma.8 Furthermore, this step forward in Europe also follows the acceptance for Priority Review of the Biologics License Application for daratumumab with the U.S. FDA on September 4, 2015.
In August 2012, Janssen Biotech, Inc. and Genmab entered an agreement which granted Janssen an exclusive worldwide license to develop, manufacture, and commercialise daratumumab.
About Multiple Myeloma
Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.9 MM is the second most common form of blood cancer, with around 39,000 new cases in Europe in 2012.10 MM most commonly affects people over the age of 65 and is more common in men than in women.11 Across Europe, five-year survival rates are 23 percent to 47 percent of people diagnosed.12 Almost 29 percent of patients with MM will die within one year of diagnosis.13 Although treatment may result in remission, unfortunately patients will most likely relapse as there is currently no cure. While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.11 Patients who relapse after treatment with standard therapies, including proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs), have poor prognoses and few treatment options available.14
About Daratumumab
Daratumumab is an investigational human monoclonal antibody that binds with high affinity to the CD38 molecule, which is found on the surface of multiple myeloma cells. It is believed to induce rapid tumour cell death through multiple immune-mediated mechanisms, including complement-dependent cytotoxicity, antibody-dependent cellular phagocytosic and antibody-dependent cellular cytotoxicity, as well as via induction of apoptosis.5 Five Phase 3 clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases in which CD38 is expressed, such as smouldering myeloma and non-Hodgkin lymphoma.