Johnson & Johnson (J&J) has announced that a subcutaneous (SC) formulation of Darzalex (daratumumab) has been approved by the European Commission (EC) as part of a combination treatment for newly diagnosed multiple myeloma (NDMM).
The drug has been authorised for use in combination with bortezomib, lenalidomide and dexamethasone (VRd) to treat NDMM patients who are eligible for an autologous stem cell transplant (ASCT).
The EC’s decision was supported by positive results from the late-stage PERSEUS study, which randomised more than 700 ASCT-eligible NDMM patients to receive either Darzalex SC plus VRd as an induction and consolidation therapy, followed by Darzalex SC and lenalidomide maintenance therapy, or VRd during induction and consolidation, followed by lenalidomide maintenance.
The Darzalex-based regimen was shown to reduce the risk of disease progression or death by 58% compared to VRd after a median follow-up of 47.5 months, and resulted in deeper responses.
More than 35,000 people were diagnosed with multiple myeloma (MM), an incurable blood cancer that affects a type of white blood cell called plasma cells, in the EU in 2022.
First approved by the EC for MM in 2016, Darzalex is a monoclonal antibody that has been designed to attach to the protein CD38, which is found in high amounts on abnormal white blood cells in multiple myeloma. By attaching to CD38 on these cells, the drug activates the immune system to kill the abnormal white blood cells.
Edmond Chan, senior director, EMEA therapeutic area lead haematology, Innovative Medicine, J&J, said: “The EC’s approval of this [Darzalex] quadruplet regimen marks a pivotal step forward in the treatment of NDMM.
“By incorporating [Darzalex] SC into this regimen we are further optimising frontline therapy for patients, building on our aim to transform outcomes, and establish new standards of care for eligible patients from induction through to maintenance.”
The authorisation comes less than a month after the EC approved J&J’s Yuvanci (single tablet combination therapy of macitentan and tadalafi) as a long-term treatment for pulmonary arterial hypertension. The regulator also recently approved the company’s Rybrevant (amivantamab) as part of a combination treatment for a new subset of advanced lung cancer patients.