EC grants marketing authorisation for Takeda’s Ninlaro capsules


The European Commission (EC) has granted conditional marketing authorisation for Takeda Pharmaceutical’s Ninlaro capsules.

The oral proteasome inhibitor is indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have previously received at least one therapy.

The decision to approve ninlaro follows a positive opinion by the European Medicines Agency (EMA)Committee for Medicinal Products (CHMP) for Human Use in September this year.

The EC’s decision was based on data from the pivotal Phase III Tourmaline-MM1 trial, which showed that the capsule with lenalidomide and dexamethasone increased the length of progression-free survival by about 40% in patients with relapsed and refractory multiple myeloma.

The company is planning follow-up analyses for overall survival next year.

"When developing ninlaro, Takeda Oncology’s scientists sought to formulate an efficacious and unique oral proteasome inhibitor with a manageable safety profile."

Takeda Oncology president Christophe Bianchi said: “When developing ninlaro, Takeda Oncology’s scientists sought to formulate an efficacious and unique oral proteasome inhibitor with a manageable safety profile.

“Ninlaro has the potential to help European patients with relapsed multiple myeloma by removing some of the barriers that can stand in the way of optimal treatment. With ninlaro, our hope is that many patients will be able to continue therapy until disease progression.”

Following the EC approval, ninlaro is now approved for use across the European Economic Area, which includes the 28 member states, as well as Norway, Liechtenstein and Iceland.

The inhibitor is also licensed for use in the US, Canada, Israel, Australia and Venezuela, and Takeda.

Ninlaro is also being studied across the continuum of multiple myeloma treatment settings, as well as systemic light-chain amyloidosis and was approved by the US Food and Drug Administration in November last year.

In the US, it is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma.