Ixaomib Designated Breakthrough Therapy for AL Amyloidosis
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.
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.