The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, which had recommended the regimen.
“This is an important decision for healthcare professionals and patients, as it provides flexibility in administration that may help address individual patient needs,” Catherine Taylor, Janssen’s Europe, Middle East and Africa (EMEA) Hematology Therapeutic Area Lead, said in a press release.
The decision was based on results from a Phase 1b trial (NCT01998971), called EQUULEUS, which showed similar safety and pharmacokinetics (a compound’s absorption, distribution, metabolism, and excretion) of Darzalex, comparing single with split infusions of the first dose in patients with multiple myeloma.
Darzalex, created by Genmab, is an antibody targeting the CD38 protein, found in high amounts on the surface of myeloma cells at all stages of the disease. Darzalex induces myeloma cell death by direct mechanisms, and by immune-dependent processes.
Prior studies showed that Darzalex decreased levels of specific subsets of immune myeloid derived suppressor cells, as well as of regulatory T- and B-cells, which are immunosuppressive cells that prevent the immune system from properly acting on cancer cells.
In September, the European Commission approved Darzalex in combination with standard therapy comprising Velcade (bortezomib), melphalan, and prednisone, for newly diagnosed adult multiple myeloma patients who cannot receive a stem cell transplant. A similar approval in the U.S. had been issued in May.
Darzalex is also approved in Europe as a stand-alone agent for patients who have failed prior therapies, including a proteasome inhibitor and an immunomodulatory therapy, and in combination with Revlimid (lenalidomide)/Velcade and dexamethasone for patients who received at least one previous therapy.
The therapy is also being assessed as a first-line option and a medicine for patients with relapsed disease. “We are committed to the development of new treatments, combinations, and formulations that will support people living with multiple myeloma across the full disease spectrum,” Taylor said.
Darzalex is also being investigated for the treatment of smoldering myeloma.