Johnson and Johnson (J&J) has announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex (daratumumab)-based quadruplet therapy for multiple myeloma.
The company is aiming for the approval of the Darzalex subcutaneous formulation combined with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).
A type II variation application is submitted when a company is seeking approval for a marketing authorisation that may have a major impact on the safety, quality or efficacy of a medicine, but no change is made to the active pharmaceutical ingredient, the strength of the drug or the route of administration.
In the EU, regulators previously approved the Darzalex combination for patients with newly diagnosed multiple myeloma and light chain (AL) amyloidosis, a blood disease that causes a buildup of amyloids in tissues and organs. Across the EU, it was estimated that over 35,000 individuals were diagnosed with multiple myeloma in 2022, with more than 22,700 patient deaths related to the condition.
The latest regulatory submission is based on positive data from the Phase III PERSEUS trial (NCT03710603). The Phase III study, conducted in partnership with the European Myeloma Network, demonstrated a clinically meaningful reduction in the risk of disease progression or death at a median follow-up of 47.5 months, compared to the control group.
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J&J presented data from the study at the 2023 American Society of Hematology (ASH) Annual Meeting, later publishing it in the New England Journal of Medicine.
Darzalex is a CD38-directed monoclonal antibody therapy that treats multiple myeloma by inhibiting tumour cell growth and causing myeloma cell death. Multiple myeloma is a blood cancer that affects plasma cells in the bone marrow and is associated with symptoms such as persistent bone pain, continuous fatigue and repeated infection.
In 2024, the EMA has already been active in advancing multiple myeloma therapies, with positive recommendations for XNK Therapeutic’s cell therapy Evencaleucel and Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel).
In a 6 March press release, Dr Craig Tendler, J&J’s vice president of clinical development, diagnostics, and global medical affairs said: “The impressive results from the PERSEUS study highlight the potential of this daratumumab subcutaneous-based regimen to transform patient outcomes and provide an effective therapy option in newly diagnosed, transplant-eligible multiple myeloma.”
