The European Commission granted full approval for Janssen Biotech’s CD38-targeting monoclonal antibody Darzalex® (daratumumab) as combination therapy with lenalidomide and dexamethasone, or Velcade® (bortezomib) and dexamethasone, for treating relapsed or refractory multiple myeloma (MM) in adult patients who have received at least one prior therapy.

European approval of Darzalex for the MM indication is based on data from the Phase III POLLUX (MMY3003) and CASTOR (MMY3004) studies, together involving more than 1000 patients, which showed that combination therapy including daratumumab reduced the risk of disease progression or death by 61% to 63% when compared with standard of care regimens.

The EC’s clearance of Darzalex also converts to full approval a prior conditional approval granted in Europe last year for use of Darzalex as monotherapy for MM in adults who had received prior proteasome inhibitor (PI) and immunomodulatory drug therapy and whose disease had progressed on their last treatment. The conditional approval had been based on the Phase II SIRIUS and Phase I/II GEN501 trials, and other supporting studies, but was dependent on Janssen providing subsequent data from POLLUX and CASTOR.

“Data from both the CASTOR and POLLUX studies demonstrated improved progression-free survival and a reduction in disease progression or death compared to standard of care,” said clinical trial investigator Torben Plesner, M.D., at Denmark’s Vejle Hospital. “Together, these results show daratumumab in combination with either a proteasome inhibitor or an immunomodulatory agent has the potential to provide clinical benefit to patients after one or more lines of therapy.”

Janssen has developed daratumumab through an exclusive global license agreement for the drug with Genmab, signed in 2012. The first commercial sales of the drug in Europe under the expanded label will trigger milestone payments of $48 million milestone from Janssen Biotech to Genmab.

“We are very pleased that Darzalex is now approved in Europe in combination with other standard MM 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., Genmab CEO.

Darzalex was granted accelerated approval by the FDA in November 2015 as monotherapy in patients with MM who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. Full FDA clearance, including the combination therapy indication, was granted a year later, also based on the CASTOR and POLLOX studies.

Within the last month, Janssen Biotech confirmed that it was halting a Phase II study evaluating Darzalex monotherapy in non-Hodgkin’s lymphoma after the first stage of the trial failed to meet its primary endpoints.
 








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