Janssen-Cilag, part of Johnson & Johnson, has received approval from the European Commission (EC) for an indication extension of Darzalex (daratumumab) in certain myeloma patients.
The approval allows the use of a subcutaneous (SC) formulation of Darzalex with bortezomib, lenalidomide, and dexamethasone (VRd) for patients with newly diagnosed multiple myeloma (NDMM) eligible for autologous stem cell transplant (ASCT).
Patients can now access this daratumumab SC-based quadruplet therapy at diagnosis.
The therapy received a positive Committee for Medicinal Products for Human Use (CHMP) opinion in September. Janssen-Cilag then submitted a Type II variation application to the European Medicines Agency (EMA) shortly thereafter.
The SC formulation was previously approved by the EC in June 2020.
This latest approval is backed by data from the Phase 3 PERSEUS study which enrolled 709 patients. It evaluated the daratumumab SC-based quadruplet regimen for induction and consolidation therapy.
This was followed by daratumumab SC and lenalidomide (D-R) maintenance therapy, compared to VRd during induction and consolidation, followed by lenalidomide (R) maintenance.
Findings from the PERSEUS study, after a median follow-up of 47.5 months, showed a significant improvement in progression-free survival (PFS).
The Darzalex regimen reduced the risk of disease progression or death by 58% compared to VRd. It also led to deeper responses, with an overall minimal residual disease (MRD) negativity rate of 75.2%.
Johnson & Johnson innovative medicine haematology EMEA therapeutic area lead and senior director Edmond Chan said: “The European Commission’s approval of this daratumumab quadruplet regimen marks a pivotal step forward in the treatment of newly diagnosed multiple myeloma.
“By incorporating daratumumab 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 overall safety profile of daratumumab-VRd was consistent with the established safety profiles of both daratumumab SC and VRd.
Johnson & Johnson is planning to assess the potential of daratumumab across the whole disease spectrum of multiple myeloma.
Janssen Biotech, a Johnson & Johnson company, entered a worldwide agreement with Genmab in August 2012. The deal grants Johnson & Johnson a license to develop, manufacture, and commercialise daratumumab.
Recently, Johnson & Johnson submitted an application to the US Food and Drug Administration (FDA) for Darzalex Faspro-based regimen for NDMM patients for whom transplant is not planned.
