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The US Food and Drug Administration (FDA) announced yesterday that the agency has granted approval to ixazomib (Ninlaro) in combination with lenalidomide and dexamethasone for the treatment of patients having multiple myeloma, who have been treated with minimum one prior therapy.
Ixazomib is the first ever proteasome inhibitor to receive FDA approval. It has been given priority review and had got orphan drug designation.
Ixazomib has got the approval on the basis of efficacy results out of the TOURMALINE-MM1 trial. The trial contained 722 patients with myeloma who had already received prior treatment with between 1 and 3 other therapies. The participants were randomly assigned to lenalidomide and dexamethasone with (n = 360) or without (n = 362) ixazomib.
In February, the manufacturer declared results of an interim analysis and said that the trial had met its primary endpoint. The findings suggested that patients given ixazomib had notably improved progression-free survival in comparison to the ones with lenalidomide and dexamethasone alone.
The ones, who were assigned ixazomib more commonly, suffered diarrhea, thrombocytopenia, constipation, nausea, peripheral edema, peripheral neuropathy, vomiting, and back pain than patients on the lenalidomide/dexamethasone arm of the trial.
On the basis of the clinical trials’ results, the recommended starting dose of ixazomib is 4 mg orally on 1st, 8th, and 15th day of a 28-day cycle in combination with lenalidomide 25 mg every day on days 1 through 21 and dexamethasone 40 mg on days 1, 8, 15, and 22 of a treatment cycle of 28 days.