Janssen-Cilag International NV has announced on Friday 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).
Company says that 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.
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),6 and data from the Phase 1/2 GEN501 monotherapy study, recentlypublished 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.