Darzalex granted European Commission approval for multiple myeloma patients
Janssen-Cilag International NV (Janssen), a Johnson & Johnson company, said it recently won approval from the European Commission (EC) to combine its first-in-class CD38-directed monoclonal antibody Darzalex (daratumumab) with other drugs to treat adult multiple myeloma patients with a minimum of one previous therapy.
Janssen said in a release that physicians will be able to administer the product in conjunction with either lenalidomide and dexamethasone, or bortezomib (Velcade) and dexamethasone.
“This approval is an important step for people living with multiple myeloma across our region and offers some patients a new treatment option,” Dr. Catherine Taylor, haematology therapeutic area lead for Janssen Europe, Middle East and Africa, said in the release. “We are encouraged by the data we have seen for daratumumab to date and will continue to investigate its potential.”
Dr. Torben Plesner of Vejle Hospital in Vejle, Denmark, who served as a daratumumab clinical trial investigator, said studies confirmed improved chances of survival and lowered incidence of disease progression. “(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,” Plesner said in the release.
The EC’s authorization was informed by data from the drug’s clinical study results, published in the New England Journal of Medicine during 2016.
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