Johnson & Johnson (J&J) has received approval from the European Commission (EC) for its subcutaneous (SC) Darzalex (daratumumab)-based quadruplet regimen in newly diagnosed multiple myeloma (MM).
The SC formulation of Darzalex is now authorised for use in combination with bortezomib, lenalidomide and dexamethasone (VRd) in the frontline setting, regardless of patients’ transplant eligibility.
More than 35,000 people in the EU were diagnosed with MM, a currently incurable blood cancer, in 2022 alone.
Darzalex is a monoclonal antibody that is designed to inhibit tumour cell growth by attaching to the CD38 protein, which is found in high amounts on abnormal white blood cells in MM.
The drug is now approved for nine MM indications, including as part of treatment regimens for newly diagnosed patients who are eligible or ineligible for an autologous stem-cell transplant (ASCT).
The EC’s latest decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the phase 3 CEPHEUS study, which compared Darzalex SC-VRd against VRd alone in newly diagnosed MM patients who were transplant ineligible or for whom ASCT was not planned as initial therapy.
At a median follow-up of 59 months, the primary endpoint was met, with an overall minimal residual disease (MRD)-negativity rate of 60.9% for patients randomised to receive Darzalex SC-VRd compared to 39.4% for those in the VRd cohort.
The amount of patients achieving sustained MRD-negativity of at least 12 months almost doubled with Darzalex SC-VRd compared to VRd, at 48.7% versus 26.3%, and J&J’s regimen significantly increased the depth of response with higher rates of complete response or better.
The quadruplet regimen also reduced the risk of progression or death by 43%, and the overall safety profile of Darzalex SC-VRd was consistent with the known profiles for Darzalex SC and VRd.
Jordan Schecter, vice president, disease area leader, multiple myeloma, J&J Innovative Medicine, said: “This landmark approval enables us to offer all patient populations access regardless of age, fitness or risk to a Darzalex-based triplet or quadruplet regimen in the frontline setting – a critical step towards our ultimate goal of delivering a functional cure.”