MLN 9708 has Breakthrough status from FDA and starts TOURMALINE-ALI Phase III trial for Amyloidosis- Takeda + Millennium

Takeda Pharmaceutical Company Limited announced that the FDA has granted Breakthrough Therapy status to the company's investigational, oral proteasome inhibitor, ixazomib (MLN 9708), for the treatment of relapsed or refractory systemic light-chain (AL) Amyloidosis. This is the first proteasome inhibitor and first investigational therapy for AL Amyloidosis to receive Breakthrough Therapy designation.

The development program for ixazomib in this indication progressed directly from a Phase I to a Phase II clinical trial, TOURMALINE-AL1, which is currently evaluating ixazomib plus dexamethasone in patients with relapsed or refractory AL amyloidosis. This is the only Phase III trial for relapsed or refractory AL Amyloidosis and it is recruiting globally.