24 November 2016 - Approval based on TOURMALINE-MM1 study results, which demonstrated statistically significant six-month improvement in progression-free survival.
Takeda Pharmaceutical Company Limited today announced that the European Commission has granted conditional marketing authorisation for Ninlaro (ixazomib citrate) 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 EMA CHMP in September 2016.