Summary
- On September 20, 2024, the FDA approved isatuximab-irfc for adults with newly diagnosed multiple myeloma who are not eligible for ASCT.
- The drug is taken in combination with bortezomib, lenalidomide, and dexamethasone.
- The approval was based on a phase 3 trial that showed an improvement in progression-free survival with the new drug combination.
- Common adverse reactions include upper respiratory tract infection, diarrhea, and fatigue.
- Healthcare professionals are encouraged to report any suspected adverse events related to the drug to the FDA.
The Food and Drug Administration has recently approved a new treatment option for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant. The medication, isatuximab-irfc (Sarclisa), in combination with bortezomib, lenalidomide, and dexamethasone, has shown significant improvements in progression-free survival compared to the standard treatment in clinical trials.
The main efficacy outcome measure was a 40% reduction in the risk of disease progression or death with the new treatment regimen. Common adverse reactions include upper respiratory tract infection, diarrhea, fatigue, and other symptoms. Healthcare professionals are encouraged to report any serious adverse events associated with the medication to the FDA. This new treatment option provides hope for those with newly diagnosed multiple myeloma who are not eligible for other forms of treatment.
Source link
Oncology, FDA, multiple myeloma, isatuximab-irfc, bortezomib, lenalidomide, dexamethasone