News
FDA approves daratumumab for multiple myeloma
Approval was based on an objective response rate of 29% with a median response duration of 7.4 months in 106 patients with relapsed or refractory...
Ixazomib has been approved by the Food and Drug Administration to be used in a combination treatment for patients with multiple myeloma who have received at least one other treatment for their disease, the agency announced on Nov. 20.
Approval was based on a randomized, double-blind clinical trial of 722 patients with multiple myeloma who had received at least one prior treatment. Compared with patients receiving lenalidomide, dexamethasone, and placebo, those receiving lenalidomide, dexamethasone, and ixazomib had a statistically significant improvement in progression-free survival (PFS). The median PFS for the ixazomib arm was 20.6 months, compared with 14.7 months for the placebo, lenalidomide, and dexamethasone arm.
Common adverse reactions occurring more often in ixazomib-treated patients included diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.
Secondary outcome measures are still being evaluated for ixazomib in this ongoing trial. Efficacy measures include overall survival, overall response rate, duration of response and time to progression. Secondary safety and quality of life–related measures include tracking adverse events, lab value abnormalities, as well as performance status and global health status.
Ixazomib, marketed as Ninlaro by Takeda Pharmaceuticals, is the first FDA-approved oral proteasome inhibitor. Proteasome inhibitors as a class take advantage of tumor cells’ reliance on proteasomal clearance of unwanted proteins; ixazomib and other proteasome inhibitors have an antiproliferative effect and promote tumor cell apoptosis. The drug was approved early under the FDA’s priority review program.
“The field of cancer treatment, and multiple myeloma in particular, has never seen a watershed moment like this,” Walter M. Capone, president and CEO of the Multiple Myeloma Research Foundation, said in a statement. He noted that on Nov. 16, the FDA approved daratumumab, the first monoclonal antibody approved to treat multiple myeloma.
Clinical trials are currently underway to investigate the use of ixazomib in patients with residual multiple myeloma, as maintenance therapy following autologous and stem cell transplant procedures for multiple myeloma, and in other cancer types.
On Twitter @karioakes