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If approved by the FDA, Darzalex Faspro may be the first treatment for smoldering multiple myeloma as compared to treating the disease once it progresses.
An application seeking to approve Darzalex Faspro for smoldering multiple myeloma has been sent to the FDA.
An application has been submitted to the Food and Drug Administration (FDA) seeking the approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of adults with high-risk smoldering multiple myeloma.
The application submission was announced in a press release from Johnson & Johnson, the manufacturer of Darzalex Faspro.
Smoldering multiple myeloma, according to the National Cancer Institute, is a slow-growing type of myeloma during which abnormal plasma cells create too much of a single type of a protein called a monoclonal antibody. This protein is either passed in the urine or builds up in blood. Patients with smoldering multiple myeloma often have no symptoms, highlighting the importance of regular check-ups for potential progression to fully developed multiple myeloma.
“There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with smoldering multiple myeloma at high risk of progressing to active multiple myeloma,” Dr. Yusri Elsayed, Global Therapeutic Area Head, Oncology, Innovative Medicine at Johnson & Johnson, said in the release. “Darzalex (daratumumab) has changed the standard of care in multiple myeloma, and with these submissions to the FDA and [European Medicines Agency], this therapy could become the first approved treatment for patients with high-risk smoldering multiple myeloma, potentially shifting the treatment paradigm.”
Progression-free survival: the time during and after treatment when a patient with cancer lives with the disease without worsening.
Overall response rate: the percentage of patients with a complete or partial response to therapy.
Overall survival: the time when a patient with cancer is still alive.
The application to the FDA was supported by findings from the ongoing phase 3 AQUILA study, which is assessing Darzalex Faspro as monotherapy (the use of a single drug) for patients with high-risk smoldering multiple myeloma. In this trial, Darzalex Faspro will be compared with active monitoring in a total of 390 patients diagnosed with smoldering multiple myeloma in the past five years. Of note, patients were excluded from the trial if they were previously treated with investigational or approved treatments for smoldering multiple myeloma or multiple myeloma, according to the release.
The main area of interest for researchers conducting this trial is progression-free survival. Other areas of focus include overall response rate, time to progression and overall survival.
The first findings from the AQUILA trial, according to the release, will be presented at an upcoming oncology conference, particularly the 2024 American Society of Hematology Annual Meeting in December.
Of the patients diagnosed with multiple myeloma, 15% of them are classified as having smoldering multiple myeloma, as noted in the release, and half of these patients with high-risk disease will likely progress to active multiple myeloma in the next two years. At the moment, patients with smoldering multiple myeloma are typically not treated until their disease develops into active multiple myeloma, meaning that those with smoldering multiple myeloma often undergo observation for signs of disease progression.
Darzalex Faspro was approved by the FDA in May 2020, and since then, it has been approved for nine other indications in multiple myeloma, according to the release. Of those nine other indications, four are for frontline treatment of patients newly diagnosed with multiple myeloma regardless of transplant eligibility.
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