FDA Approval
The FDA approval of Farydak was based on a randomized, double-blind, placebo-controlled, multicenter study in patients with relapsed multiple myeloma who had received 1 to 3 prior lines of therapy. A total of 768 subjects received bortezomib (1.3 mg/m2 injected intravenously) with dexamethasone (20 mg) in addition to Farydak 20 mg (or placebo), taken orally every other day, for 3 doses per week in Weeks 1 and 2 of each 21-day cycle. Treatment was administered for a maximum of 16 cycles (48 weeks). The primary endpoint was progression-free survival (PFS), using modified European Bone Marrow Transplant Group (EBMT) criteria, as assessed by the investigators. In the overall trial population, the median PFS was 12 months in the Farydak, bortezomib, dexamethasone arm and 8.1 months in the placebo, bortezomib, dexamethasone arm. At the time of interim analysis, overall survival was not statistically different between arms. The approval of Farydak was based upon the efficacy and safety in a prespecified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an immunomodulatory agent and a median of 2 prior therapies as the benefit:risk appeared to be greater in this more heavily pretreated population than in the overall trial population. Of these 193 patients, 76% of them had received ≥2 prior lines of therapy. The median PFS was 10.6 months in the Farydak, bortezomib, and dexamethasone arm and 5.8 months in the placebo, bortezomib, and dexamethasone arm.
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The FDA approval of Farydak was based on a randomized, double-blind, placebo-controlled, multicenter study in patients with relapsed multiple myeloma who had received 1 to 3 prior lines of therapy. A total of 768 subjects received bortezomib (1.3 mg/m2 injected intravenously) with dexamethasone (20 mg) in addition to Farydak 20 mg (or placebo), taken orally every other day, for 3 doses per week in Weeks 1 and 2 of each 21-day cycle. Treatment was administered for a maximum of 16 cycles (48 weeks). The primary endpoint was progression-free survival (PFS), using modified European Bone Marrow Transplant Group (EBMT) criteria, as assessed by the investigators. In the overall trial population, the median PFS was 12 months in the Farydak, bortezomib, dexamethasone arm and 8.1 months in the placebo, bortezomib, dexamethasone arm. At the time of interim analysis, overall survival was not statistically different between arms. The approval of Farydak was based upon the efficacy and safety in a prespecified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an immunomodulatory agent and a median of 2 prior therapies as the benefit:risk appeared to be greater in this more heavily pretreated population than in the overall trial population. Of these 193 patients, 76% of them had received ≥2 prior lines of therapy. The median PFS was 10.6 months in the Farydak, bortezomib, and dexamethasone arm and 5.8 months in the placebo, bortezomib, and dexamethasone arm.
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