The Food and Drug Administration (FDA) has approved Ninlaro (ixazomib; Takeda) capsules in combination with lenalidomide (RevlimidCelgene) and dexamethasone for the treatment of patients with multiple myeloma who have received ≥1 prior therapy. 

Ninlaro is an oral proteasome inhibitor that works by blocking enzymes from multiple myeloma cells. The approval was based on data from an international, randomized, double-blind clinical trial (n=722) that evaluated patients whose multiple myeloma returned or those who did not respond to prior treatment. Study patients received either Ninlaro with lenalidomide and dexamethasone or placebo plus lenalidomide and dexamethasone. The Ninlaro group demonstrated longer progression-free survival compared to the placebo group. (average 20.6 months vs. 14.7 months).

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Ninlaro was granted priority review and orphan drug designations by the FDA. Other recently approved products for multiple myeloma include Darzalex (daratumumab; Janssen Biotech) and Farydak (panobinostat; Novartis).

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