Myeloma Minute: FDA Approves Ninlaro
IMF Applauds FDA Approval of Ninlaro (Ixazomib) for Treatment of Relapsed Myeloma
The International Myeloma Foundation (IMF) applauds today’s approval by the US Food and Drug Administration (FDA) of Takeda Oncology’s Ninlaro (ixazomib), an oral, once-weekly proteasome inhibitor, for use in combination with lenalidomide and dexamethasone to treat people with multiple myeloma who have received at least one prior therapy.
“On behalf of myeloma patients across the US, the IMF is pleased with today’s FDA approval of Ninlaro,” said Susie Novis Durie, President and Co-founder of the International Myeloma Foundation, the oldest and largest myeloma foundation in the world. “Oral treatments like Ninlaro provide myeloma patients new options for treatment. Options that can improve quality of life for patients is something the IMF has worked tirelessly to achieve for 25 years.”
Dr. Brian Durie, Chairman of the International Myeloma Foundation, said, "The IMF is pleased by the approval of ixazomib. This opens the door for a fully oral proteasome inhibitor-based triplet combination therapy. Having worked in multiple myeloma for decades, I’ve seen notable progress, yet significant unmet needs remain. With today’s approval, we now have another attractive and rather well-tolerated option for many patients living with multiple myeloma.”
The safety and efficacy of Ninlaro were demonstrated in an international, randomized, double-blind clinical trial of 722 patients whose multiple myeloma came back after, or did not respond to, previous treatment. Study participants received either Ninlaro in combination with lenalidomide and dexamethasone or placebo plus lenalidomide and dexamethasone. Those taking Ninlaro in combination with lenalidomide and dexamethasone lived longer without their disease worsening (average 20.6 months) compared to participants taking the other regimen (14.7 months).
For more information, please contact the IMF InfoLine team toll free at (800) 452-CURE (2873) or by email at InfoLine@myeloma.org.
To watch “What Is Ixazomib?” episode of IMF’s video series “#AskDrDurie, click HERE.