EU approves Ninlaro (ixazomib) capsules in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma- Takeda

Takeda Pharmaceutical has announced that the European Commission has granted conditional marketing authorization for Ninlaro (ixazomib) capsules, indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy. The decision to approve Ninlaro as the first and only oral proteasome inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products (CHMP) for Human Use in September 2016.

The European Commission followed the CHMP’s recommendation to approve Ninlaro based on data from the pivotal Phase III TOURMALINE-MM1 trial, which demonstrated that Ninlaro plus lenalidomide and dexamethasone increased the length of progression-free survival by about six months, or 40 percent, in patients with relapsed and refractory multiple myeloma when compared with placebo, lenalidomide and dexamethasone. The study also showed that the progression-free survival benefit observed in the Ninlaro regimen extended across pre-specified subgroups of patients. Follow-up analyses for overall survival are planned for 2017.