J&J’s Darzalex-VRd can now be given to newly diagnosed MM patients eligible for ASCT. Credit: Michael Vi/Shutterstock

The European label for Johnson and Johnson Innovation Medicine’s (J&J) Darzalex (daratumumab) has been expanded to include patients with newly diagnosed multiple myeloma (MM) eligible for autologous stem cell transplant (ASCT).

The label expansion for the anti-CD38 antibody was supported by data from the ongoing Phase III PERSEUS trial that was submitted to to the European Medicines Agency in March 2024.

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Darzalex initially received approval as a monotherapy for MM from the EC in May 2016. Along with MM, the antibody is marketed for treating primary system amyloidosis, and is in clinical studies for a range of oncological, immunological, and metabolic disorders.

Projections from GlobalData estimate the drug will generate $11.5bn in revenue this year, set to increase to an annual $20bn in revenue by 2030.

GlobalData is the parent company of Pharmaceutical Technology.

Co-formulated with Halozyme’s Enhanze drug delivery technology, Darzalex is the only subcutaneous, CD38-targeting MM treatment approved.

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The PERSEUS trial (NCT03710603) found that a Darzalex-VRd quadruple regimen resulted in a 58% reduced risk of disease progression or death compared to bortezomib, lenalidomide, and dexamethasone alone. Among 709 randomised MM patients, Darzalex therapy led to improved minimal residual disease (MRD) negativity (75.2% vs 47.5%), complete response (87.9% vs 70.1%), and sustained MRD negativity for ≥12 months (64.8% vs 29.7%).

The quadruple regimen of Darzalex with bortezomib, lenalidomide, and dexamethasone received US Food and Drug Administration (FDA) approval for the same indication in July 2024, following FDA approvals to treat MM for Darzalex with bortezomib, thalidomide and dexamethasone (VDd) in 2019 and as a monotherapy in 2015. In the UK, Darzalex monotherapy was approved to treat MM by the National Institute for Health and Care Excellence (NICE) in January 2018. NICE later published guidance recommending Darzalex VDd for MM in April 2023.