Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended approval for ixazomib in combination with lenalidomide and dexamethasone for patients with multiple myeloma (MM) who have received at least one prior therapy.
The decision was based on the results of the phase III TOURMALINE-MM1 study that demonstrated a 26 percent reduction in the risk of disease progression or death with the ixazomib combination therapy (n=360) compared with lenalidomide and dexamethasone alone (n=362). The median progression-free survival with the ixazomib combination was 20.6 months compared with 14.7 months with lenalidomide and dexamethasone alone (hazard ratio = 0.74; 95% CI 0.59-0.94; p=0.01).
Earlier this year, CHMP recommended against ixazomib for patients with relapsed/refractory MM, citing insufficient clinical benefit.
Read the full results of the TOURMLINE-MM1 study.
Source: Takeda press release, September 16, 2016.