Takeda’s Ninlaro approved in Europe for multiple myeloma

Takeda has announced that its cancer drug Ninlaro has been conditionally approved by the European Commission for the treatment of multiple myeloma.

The capsules are now indicated for use in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy.

It follows the decision of the European Medicines Agency's Committee for Medicinal Products for Human Use in September to recommend the drug, which was based on positive data from the the pivotal phase III TOURMALINE-MM1 trial.

This study demonstrated that Ninlaro plus lenalidomide and dexamethasone increased the length of progression-free survival by about six months in patients with relapsed and refractory multiple myeloma, when compared with a placebo-based regimen.

Additionally, the progression-free survival benefit observed in the Ninlaro regimen was shown to extend across pre-specified subgroups of patients.

Dr Christophe Bianchi, president of Takeda Oncology, said: "We will continue to study Ninlaro in a variety of settings in the hopes that we can bring this medicine to as many of the patients who may benefit from it as possible."

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