Darzalex Faspro, the subcutaneous 5 minute shot version of daratumumab, has been FDA approved for use with pomalidomide and dexamethasone for multiple myeloma patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval is the sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma.
The approval was based on the APOLLO study data published in The Lancet Oncology.
"Clinical studies including APOLLO have continued to show the ability of daratumumab-based combination treatment regimens to significantly reduce the risk of progression in patients with multiple myeloma," said Meletios A. Dimopoulos, M.D.*, Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator. "With this approval, we are now able to combine pomalidomide and dexamethasone with a daratumumab subcutaneous option that can be administered in minutes rather than the hours needed for intravenous administration."
The APOLLO study targeted progression free survival as its end point. In the study, Darzalex Faspro with pomalidomide and dex reduced the risk of progression or death by 37 percent compared to pomalidomide and dex alone.
|Progression Free Survival||12.4 months||6.9 months|
|Very Good Partial Response||51%||20%|
Only 2% of patients stopped the Darzalex Faspro/Pom/Dex due to serious side effects (1 patient). The most common side effects were fatigue, pneumonia, upper respiratory tract infection, and diarrhea. The most frequent serious adverse reactions in >5 percent of patients who received Darzalex Faspro/Pom/Dex were pneumonia (15 percent) and lower respiratory tract infection (12 percent). Fatal adverse reactions occurred in 7 percent of patients who received Darzalex Faspro/Pom/Dex.
To prevent infusion related reactions, patients are pre-treated with steroids, benadryl or other histamine blocker and acetaminophen before Darzalex Faspro administration for the first and second injections.
Darzalex Faspro is currently approved for the treatment of adult patients with multiple myeloma:
The additional approval and easier administration is welcome by myeloma patients as yet another treatment combination option for the treatment of multiple myeloma.
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Myeloma survivor, patient advocate, wife, mom of 6. Believer that patients can help accelerate a cure by weighing in and participating in clinical research. Founder of HealthTree Foundation (formerly Myeloma Crowd).