FDA approves Darzalex Faspro for use in relapsed multiple myeloma
The FDA approved daratumumab and hyaluronidase-fihj for use in combination with pomalidomide and dexamethasone for treatment of patients with relapsed multiple myeloma, including those refractory to lenalidomide.
Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) is the only subcutaneous anti-CD38 monoclonal antibody approved in combination with pomalidomide (Pomalyst, Bristol Myers Squibb) and dexamethasone.
The FDA based the approval on results of the randomized phase 3 APOLLO study, which included 304 patients with relapsed or refractory multiple myeloma who received at least one prior treatment regimen, including lenalidomide (Revlimid, Bristol Myers Squibb) and a proteasome inhibitor, and experienced disease progression.
Patients in the multicenter, open-label trial received pomalidomide and low-dose dexamethasone with or without daratumumab and hyaluronidase-fihj.
PFS served as the primary endpoint. Secondary endpoints included overall response rate, rate of very good partial response or better, complete response rate and duration of response.
As Healio previously reported, results showed the addition of daratumumab and hyaluronidase-fihj to pomalidomide and dexamethasone significantly reduced risk for disease progression or death (median, 12.4 months vs. 6.9 months; HR = 0.63; 95% CI, 0.47-0.85).
A higher percentage of patients assigned daratumumab and hyaluronidase-fihj responded to therapy (69% vs. 46%), achieved complete response or better (25% vs. 4%), achieved very good partial response or better (51% vs. 20%), and achieved minimal residual disease-negative status (9% vs. 2%).
The most common adverse events among patients assigned daratumumab and hyaluronidase-fihj included fatigue, pneumonia, upper respiratory tract infection and diarrhea.
Fifty percent of patients in this treatment group experienced serious adverse events, the most common of which were pneumonia (15%) and lower respiratory tract infection (12%). Seven percent of patients experienced fatal adverse events.
"Clinical studies including APOLLO have continued to show the ability of daratumumab-based combination treatment regimens to significantly reduce the risk [for] progression [among] patients with multiple myeloma," Meletios A. Dimopoulos, MD, professor and chairman of the department of clinical therapeutics at National and Kapodistrian University of Athens School of Medicine in Greece and principal investigator of APOLLO, said in a Janssen-issued press release. “"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."