Janssen, a pharmaceutical company of Johnson & Johnson, has secured the European Commission (EC) marketing authorisation for Darzalex(daratumumab) in combination with lenalidomide and dexamethasone (DRd).

Darzalex is indicated for treating newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT).

The pharmaceutical firm said that the EC has approved Darzalex based on results from the open-label, multicentre Phase 3 MAIA study, which enrolled 737 subjects aged 45-90 years old, who were newly diagnosed with multiple myeloma, and ineligible for high-dose chemotherapy and ASCT.

MAIA study principal investigator Thierry Facon said: “Despite recent therapeutic advances, relapse of multiple myeloma is considered to be almost inevitable, becoming more challenging to treat following each relapse.

“This makes it even more important that we maximise our best response upfront to extend the first remission. This marks an important approval, especially for transplant ineligible patients, a more vulnerable population, for whom outcomes are generally poorer when compared to those who are transplant eligible.”

Daratumumab help killing tumour cells through multiple immune-mediated mechanisms

Janssen said that Daratumumab is a biologic designed to target CD38, a surface protein that is highly expressed across multiple myeloma cells, irrespective of the disease stage.

The drug is thought to induce tumour cell death through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), in addition to apoptosis.

The study demonstrated that using Daratumumab in combination with Rd would reduce the risk of disease progression or death in patients, compared to the treatment with Rd alone, said the company.

In addition, using daratumumab has resulted in deeper responses including increased rates of complete response (CR) or improved rates of very good partial response (VGPR), compared to Rd alone.

The Daratumumab-Rd combination was found to induce more than times higher rate of minimal residual disease (MRD) negativity compared to Rd alone.

Janssen Research & Development Oncology clinical development and global medical affairs vice president Craig Tendler said: “It’s gratifying to see that through our research and development efforts, daratumumab has helped over 100,000 patients globally.

“With today’s approval and the continued development of daratumumab, we hope to bring this innovative therapy to many more patients in the future.”