Janssen-Cilag International NV announced today 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). 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.
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.
Multiple myeloma (MM) is an incurable blood cancer that starts in the
bone marrow and is characterised by an excessive proliferation of plasma
cells.MM is the second most common form of blood cancer, with around 39,000 new cases in Europe in 2012. MM most commonly affects people over the age of 65 and is more common in men than in women. 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.
