FDA Approves J&J's Myeloma Drug

The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for use in newly diagnosed multiple myeloma (NDMM) patients. This treatment is intended for patients who are eligible for an autologous stem cell transplant (ASCT) and is used in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd).

This FDA approval is based on the results of the Phase III PERSEUS study. The study compared the D-VRd regimen (daratumumab, bortezomib, lenalidomide, and dexamethasone) with VRd (bortezomib, lenalidomide, and dexamethasone) in NDMM patients eligible for ASCT. The findings demonstrated that the D-VRd regimen significantly reduced the risk of disease progression or death by 60% compared to the VRd regimen, achieving a substantial improvement in progression-free survival, the primary endpoint of the trial.

In addition to the primary endpoint, the D-VRd regimen also led to higher minimal residual disease negativity rates at the end of consolidation therapy, indicating deeper responses in patients. These results suggest that the combination therapy is more effective in eradicating the disease at a molecular level.

The safety profile of the D-VRd regimen was consistent with the known side effects of its individual components. The most common adverse reactions included peripheral neuropathy, fatigue, and oedema. Despite these side effects, the benefits of the therapy in reducing disease progression and mortality rates are considered significant.

Jordan Schecter, Johnson & Johnson’s multiple myeloma disease area leader and vice-president, expressed that this approval signifies a major advancement in the treatment of newly diagnosed multiple myeloma patients who are eligible for transplants. According to Schecter, this new indication for DARZALEX FASPRO-based therapy marks a critical step in setting new standards of care for these patients, potentially offering them their deepest responses during first-line treatment.

The approval of DARZALEX FASPRO for this new indication follows a financially challenging quarter for Johnson & Johnson. The company reported a 12.8% decrease in net earnings for the second quarter of 2024, with earnings falling to $4.6 billion from $5.3 billion in the same period of the previous year. Despite this financial downturn, the FDA’s approval is a significant milestone for the company and its commitment to advancing treatment options for multiple myeloma patients.

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