The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (J&J) DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for induction and consolidation in the treatment of newly diagnosed multiple myeloma (NDMM).
The treatment is intended for use in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) in NDMM patients who are eligible for an autologous stem cell transplant (ASCT).
This latest decision by the FDA is underpinned by results from the Phase III PERSEUS study.
This trial analysed the quadruplet therapy regimen comprising D-VRd induction and consolidation therapy versus VRdin ASCT-eligible NDMM patients.
The study findings revealed that the D-VRd regimen reduced the risk of disease progression or death by 60% against VRd, a substantial improvement in progression-free survival which was the trial’s primary endpoint.
At the end of consolidation therapy, the D-VRd treatment also led to higher minimal residual disease negativity rates, indicating deeper responses.
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The safety profile of the D-VRd combination was in line with the known profiles of the individual components.
The most common adverse reactions observed were peripheral neuropathy, fatigue and oedema.
Johnson & Johnson multiple myeloma disease area leader and vice-president Jordan Schecter stated: “This latest indication for DARZALEX FASPRO-based quadruplet therapy demonstrated a clinically significant reduction in disease progression or death during first-line treatment when patients are likely to experience their deepest responses.
“The approval embodies our commitment to setting new standards of care for patients newly diagnosed with multiple myeloma who are transplant-eligible.”
The latest development comes after the company reported a 12.8% decrease in net earnings for the second quarter (Q2) of 2024, with figures falling to $4.6bn from $5.3bn in the same period of the previous year.
