Conditional EU approval for multiple myeloma drug Ninlaro

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, from Japanese drug major Takeda Pharmaceutical (TYO: 4502), as the first and only oral proteasome inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) in September 2016. This came after a previous rejection in May, which Takeda appealed. The drug was approved by US regulators in November 2015.

The conditional approval requires Takeda to provide post-approval updates on the safety and efficacy analyses for TOURMALINE-MM1 and data from ongoing studies to show the drug's long-term effects.