Janssen-Cilag International NV announced 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.
Janssen-Cilag International NV announced 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. (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 II MMY2002 (SIRIUS) monotherapy study, presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), (6) and data from the Phase I/II 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 US FDA on 4 September 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.
References
- Danylesko I, Beider K, Shimoni A, Nagler A. Monoclonal antibody-based immunotherapy for multiple myeloma. Immunotherapy 2012;4:919–38.
- Ocio EM et al. New drugs and novel mechanisms of action in multiple myeloma in 2013: a report from the International Myeloma Working Group (IMWG). Leukemia 2014;28:525–42.
- Lin P Owens R, Tricot G, Wilson CS. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol 2004;121:482–8.
- Fedele G et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNgamma cytokines and proliferation. Mediat Inflamm 2013;2013:564687.
- de Weers M et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol 2011;186:1840–8.
- Lonial S et al. Phase 2 Study of daratumumab Monotherapy in Patients with ≥3 Lines of Prior Therapy or Double Refractory Multiple Myeloma (MM). J Clin Oncol 2015;33(Suppl.): abstract LBA 8512.
- Lokhorst HM et al. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015; Aug:1–13.
- European Medicines Agency. Public Summary of Orphan Drug Designations – EU/3/13/1153. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2013/08/human_orphan_001232.jsp&mid=WC0b01ac058001d12b. Last accessed 16 September 2015.
