Genmab announces that the European Commission (EC) has granted a marketing authorization for DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
The EC approval follows a positive opinion issued for DARZALEX by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in February 2017. This approval also converts the previous conditional marketing authorization for DARZALEX to a full approval. DARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize the product.
Genmab will receive milestone payments totaling USD 48 million from Janssen Biotech, Inc. in connection with the first commercial sales of DARZALEX under the expanded label. The sales are expected to occur quickly after the approval. These milestone payments were included in the financial guidance issued by Genmab on February 22, 2017 and therefore there is no change to the company’s financial guidance following this approval.
“We are very pleased that DARZALEX is now approved in Europe in combination with other standard multiple myeloma therapies and that a far greater number of patients suffering from this incurable disease will now have access to this first-in-class immunotherapy,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The positive opinion of the CHMP was based on data from two Phase III studies: the CASTOR study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma (published in The New England Journal of Medicine in August 2016), and the POLLUX study of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma (published in the New England Journal of Medicine in October 2016). Data from two early stage studies also supported the approval: the Phase I MMY1001 study (daratumumab in combination with pomalidomide and dexamethasone) and the Phase I/II GEN503 study (daratumumab in combination with lenalidomide and dexamethasone).