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FDA approves Ninlaro for previously treated myeloma

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The FDA today approved ixazomib for use in combination with lenalidomide and dexamethasone for patients with previously treated multiple myeloma.

Ixazomib (Ninlaro, Millennium Pharmaceuticals) is the first oral proteasome inhibitor to receive FDA approval.

The FDA based its decision in part on results of a multicenter, randomized, double blind, placebo-controlled trial that included 722 patients with myeloma who underwent one to three prior therapies.

Researchers randomly assigned 360 patients to ixazomib plus lenalidomide (Revlimid, Celgene) and dexamethasone. The other 362 patients received placebo plus lenalidomide and dexamethasone. Treatment continued until disease progression or unacceptable toxicity.

Patients assigned the ixazomib regimen experienced a statistically significant improvement in median PFS (20.6 months vs. 14.7 months; HR = 0.74; 95% CI, 0.59-0.94).

Patients assigned the ixazomib regimen demonstrated increased rates of diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting and back pain.