Johnson & Johnson (J&J) has announced that its CD38-directed antibody Darzalex (daratumumab) has been recommended by the European Medicines Agency’s human medicines committee to treat smouldering multiple myeloma (SMM), an asymptomatic intermediate disease state of multiple myeloma (MM).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that a subcutaneous formulation of the drug be used as a monotherapy to treat SMM in adults who are at high-risk of developing MM.
More than 35,000 people in the EU were diagnosed with MM, a currently incurable blood cancer that affects a type of white blood cell called plasma cells, in 2022.
SMM accounts for around 15% of all new cases of the disease and is not generally treated until active MM develops. However, recent evidence has suggested that patients at high-risk for progression to active MM could benefit from earlier therapeutic intervention.
The European Commission (EC) will now review the CHMP’s positive opinion as it makes a final decision on Darzalex in this indication. If approved, Darzalex would be the first therapy approved in the EU for SMM.
The CHMP’s decision, which comes less than a month after a US Food and Drug Administration panel of experts recommended the drug for the same patient population, was supported by positive results from the late-stage AQUILA study in 390 SMM patients at high risk of progression.
At a median follow-up of 65.2 months, median progression-free survival (PFS) was not reached in the Darzalex group versus 41.5 months for the active monitoring cohort, with an estimated 60-month PFS rate of 63.1% versus 40.8%, respectively.
Ester in’t Groen, EMEA therapeutic area head haematology, J&J Innovative Medicine, said: “Early disease intervention with [Darzalex] has the potential to reduce the risk of progression to active MM or death by 51% for patients with high-risk disease.
“Pending EC approval, patients and physicians will have an option to treat high-risk SMM, with the aim to intercept this complex blood cancer before it develops into active disease and importantly, before end-organ damage occurs.”