Janssen Pharmaceutica has filed an application with the European Medicines Agency (EMA) for expanded indication of Darzalex (daratumumab) to treat multiple myeloma.

Darzalex is an injection for intravenous infusion, and is the first monoclonal antibody (mAb) to receive US Food and Drug Administration (FDA) approval to treat multiple myeloma. The IgG1k mAb is designed to bind to the CD38 molecule present on the surface of multiple myeloma cells.

The company is seeking approval for the use of the drug in combination with lenalidomide and dexamethasone (Rd) in newly diagnosed multiple myeloma patients not eligible for high dose chemotherapy and autologous stem cell transplant (ASCT).

The drug is being developed by Janssen Biotech as part of an exclusive worldwide licence from Genmab.

In Europe, Darzalex is already approved as a monotherapy and in different combinations for the treatment of adults with multiple myeloma, an incurable blood cancer that is estimated to have caused around 106,000 deaths globally in 2018.

“Darzalex is the first monoclonal antibody to receive FDA approval to treat multiple myeloma.”

Janssen’s latest submission is based on results obtained during the Phase III MAIA clinical trial conducted in a total of 737 newly diagnosed patients who were not candidates for high dose chemotherapy and ASCT.

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The trial compared daratumumab plus Rd combination with lenalidomide and dexamethasone alone. Primary endpoint of the study is progression-free survival (PFS).

Daratumumab was administered at 16mg/kg weekly for initial eight weeks, followed by every alternate week for 16 weeks and then every four weeks until progression of disease or unacceptable toxicity.

Patients received 25mg lenalidomide on days one through 21 of each 28-day cycle, and dexamethasone was given at 40mg once per week for both treatment arms.

Genmab CEO Jan van de Winkel said: “With this potential label expansion, we are hopeful that Darzalex will become available to an even wider group of multiple myeloma patients in the first line setting.”

The drug also holds US regulatory approvals in different combinations for the treatment of multiple myeloma.