Takeda announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ixazomib, an investigational oral proteasome inhibitor for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis.

Ixazomib is being studied in four Phase 3 trials: TOURMALINE-MM1, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in relapsed and/or refractory MM; TOURMALINE-AL1, investigating ixazomib plus dexamethasone in patients with relapsed or refractory AL amyloidosis; TOURMALINE-MM2, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM; and TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed MM following induction therapy and autologous stem cell transplant.

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Previously, ixazomib was granted Orphan Drug designation in multiple myeloma (MM) in 2011 and for AL amyloidosis in 2012.

For more information call (877) 825-3327 or visit Takeda.US.