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Daratumumab Subcutaneous FDA APPROVED (Darzelex FASPRO)!
I literally just posted (10 minutes ago!) comments on the recent approval of isatuximab (Sarclisa) in combination with pomalidomide and dexamethasone for the treatment of relapsed or refractory myeloma patients with at least two prior therapies. My final comment regarding advantages/disadvantages regarding isatuximab versus daratumumab-both with CD38 targets-was that in the near future, daratumumab will be available in subcutaneous formulation. And, lo and behold, TODAY, May 1st, the FDA approved daratumumab and hyaluronidase-fihj for ALL of the previous FDA indications (and schedules) of the IV formulation of daratumumab. The subcutaneous dose is 1,800 mg daratumumab and 30,000 units hyaluronidase administered subcutaneously into the abdomen over approximately 3 to 5 minutes. The adverse events essentially were identical to the IV formulation. HOWEVER, infusion reactions were substantially lower: In a pooled safety population of 490 patients who received DARZALEX FASPRO as
monotherapy or in combination, 11% of patients experienced a systemic administration-related
reaction (Grade 2: 3.9%, Grade 3: 1.4%). Systemic administration-related reactions occurred in
10% of patients with the first injection, 0.2% with the second injection, and cumulatively 0.8%
with subsequent injections. The median time to onset was 3.7 hours (range: 9 minutes to
3.5 days). Of the 84 systemic administration-related reactions that occurred in 52 patients,
73 (87%) occurred on the day of DARZALEX FASPRO administration. Delayed systemic
administration-related reactions have occurred in less than 1% of the patients.