J&J’s Myeloma Drug Gets EU Accelerated ReviewBy
Janssen-Cilag International NV, part of Johnson & Johnson, reports that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has accepted its request for an accelerated assessment the marketing authorization application (MAA) of daratumumab. This acceptance follows the earlier regulatory submission of a MAA that seeks authorization of daratumumab as a single agent for treating 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. In doing so, daratumumab triggers the patient's own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated and other mechanisms of action.
In July 2013 daratumumab was granted orphan drug status by the EMA for the treatment of plasma cell myeloma.Furthermore, this step forward in Europe also follows the acceptance for priority review of the biologics license application for daratumumab with the US Food and Drug Administration 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 commercialize daratumumab.
Source: Johnson & Johnson