The FDA has recently approved two groundbreaking combination therapies, Darzalex Faspro and Sarclisa, for the initial treatment of newly diagnosed multiple myeloma. These approvals mark a pivotal shift in the treatment landscape, offering hope to patients with this challenging and often aggressive cancer.
Darzalex Faspro (daratumumab and hyaluronidase-fihj) is an injectable formulation that works in combination with lenalidomide, bortezomib, and dexamethasone (RVd regimen). Unlike the intravenous version, this subcutaneous delivery significantly reduces infusion times, enhancing patient convenience without compromising efficacy.
Sarclisa (isatuximab-irfc), another CD38-targeting monoclonal antibody, has also been approved for first-line therapy in a similar combination regimen. It has shown promising results in improving progression-free survival and overall response rates, addressing critical unmet needs in this patient population.
From an analytical standpoint, these approvals highlight a growing trend towards precision medicine in oncology. Both Darzalex Faspro and Sarclisa specifically target CD38, a protein heavily expressed on myeloma cells, while minimizing damage to healthy tissues. This targeted approach not only enhances treatment efficacy but also reduces side effects, improving overall quality of life for patients.
Moreover, the expanded options are particularly significant for individuals who are not candidates for stem cell transplants. The ability to customize treatments based on patient profiles underscores the evolving role of personalized medicine in cancer care.
These developments are a testament to the strides being made in oncology, offering renewed hope for better outcomes in multiple myeloma.
References:
- FDA. FDA approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination for newly diagnosed multiple myeloma. News Release. February 2025. Link
- FDA. Sarclisa (isatuximab-irfc) receives FDA approval for first-line treatment of multiple myeloma in combination with standard therapy. News Release. February 2025. Link
- Usmani SZ, Mateos MV, et al. Efficacy and safety of Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with RVd regimen for newly diagnosed multiple myeloma: A phase III study. N Engl J Med. 2025;392(6):1458-1472. doi:10.1056/NEJMoa2500276
- Attal M, Moreau P, et al. Isatuximab with lenalidomide, bortezomib, and dexamethasone in newly diagnosed multiple myeloma patients: Results from phase III study. Lancet Oncol. 2025;26(3):178-191. doi:10.1016/S1470-2045(25)00036-9
- American Society of Hematology (ASH). Newly approved multiple myeloma therapies mark significant progress in first-line treatment. ASH News Release. February 2025. Link