Daratumumab is a first-in-class biologic designed to target CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.
Daratumumab is considered to induce tumour cell death via multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
The approval was based on data from the phase 3 MAIA (MMY3008) study, which comprised of 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT aged 45-90 years old.
The company has randomised the patients in the open-label and multicentre study to secure either daratumumab-Rd or Rd alone in 28-day cycles. The progression-free survival is the primary endpoint of the trial.
According to the company, daratumumab in combination with Rd significantly minimised the risk of disease progression or death by 44% in patients with newly diagnosed multiple myeloma who are transplant ineligible compared against treatment with Rd alone.
In Europe, daratumumab is also approved in combination with bortezomib, melphalan and prednisone to treat adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
In August 2012, Janssen Biotech secured an exclusive licence from Genmab to develop, manufacture and commercialise daratumumab.
Janssen Research & Development oncology clinical development and global medical affairs vice president Dr 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.”
In August this year, Janssen has also secured approval from the EC for two new indications of Imbruvica (ibrutinib).
The approval has been granted for the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL), as well as the use of ibrutinib plus rituximab to treat adult patients with Waldenström’s macroglobulinemia (WM).