Janssen's Darzalex has received a condition approval in Europe for the treatment of multiple myeloma, offering patients with the disease access to a novel active immunotherapy.
The decision means the drug can now be used as monotherapy in adult patients with relapsed and refractory multiple myeloma (MM), whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
Darzalex (daratumumab) is the first CD38-directed monoclonal antibody approved in Europe. It works by binding to the CD38 signalling molecule, which highly expressed on the surface of multiple myeloma cells regardless of stage of disease, triggering the immune system to attack and kill cancer cells.
Conditional approval allows the CHMP to recommend a medicine for marketing authorisation in the interest of public health where the benefit of its immediate availability to patients outweighs the risk inherent in the fact that additional data are still required.
In this case, the decision was based primarily based on two studies; in one, tumours shrank or could no longer be seen in 29 percent of patients taking the drug over an average of 7.4 months; and in the second, tumours shrank or could no longer be seen in 36 percent.
Findings from a combined efficacy analysis demonstrated that, after a mean follow-up of 14.8 months, the estimated median overall survival for single-agent daratumumab was 20 months, while the overall response rate was 31 percent, and 83 percent of patients achieved stable disease or better.
Janssen must provide results from two Phase III studies of Darzalex used in combination with standard treatments for the disease (lenalidomide/dexamethasone and bortezomib/dexamethasone) for regulators to consider a full approval.
"Daratumumab has shown promising efficacy results and a manageable safety profile as a single agent for heavily pre-treated and refractory myeloma patients," said Professor Jesús San Miguel, director of Clinical & Translational Medicine, Universidad de Navarra, Spain. "Overall survival improved significantly in these patients, whose prognosis is typically very poor, and who therefore have the greatest need for new treatments."
The drug was approved in the US in November last year.