The approval of FARYDAK was based upon the efficacy and safety in a subgroup analysis of 147 patients who had received at least 2 prior regimens, including bortezomib (BTZ) and an immunomodulatory drug (IMiD).
*Patients had measurable disease at screening, defined by serum M protein of ≥1 g/dL or urine M protein of ≥200 mg/24 h. BTZ-refractory patients were excluded.3
†FARYDAK 20 mg was taken once a day, 3 times per week on a 2-weeks-on, 1-week-off dosing regimen, in combination with BTZ 1.3 mg/m2 IV and dex 20 mg.2
‡As per modified European Bone Marrow Transplant Group (mEBMT) criteria and as assessed by the investigator.1
§CR was defined as absence of M protein in serum and urine by immunofixation for ≥6 weeks, <5% plasma cells in bone marrow, no increase in size or number of lytic bone lesions from baseline, and disappearance of soft tissue plasmacytomas (if present at baseline). All CR criteria apply to nCR, except that absence of serum and urine M protein cannot be confirmed by immunofixation.3