Takeda receives CHMP backing for EU approval of Ninlaro

Takeda has announced that its new multiple myeloma therapy Ninlaro has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the conditional approval of Ninlaro capsules in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Results from the phase III trial TOURMALINE-MM1 have shown that the addition of Ninlaro to lenalidomide and dexamethasone was associated with a significant improvement in progression-free survival rates compared to placebo.

If the drug receives final approval from the European Commission, Ninlaro will become the first and only oral proteasome inhibitor approved for use across the European Economic Area.

Dr Christophe Bianchi, president of Takeda Oncology, said: "Today's positive CHMP opinion for the conditional approval of Ninlaro is an important first step to bringing this treatment to a relapsed and/or refractory patient population where there is a significant unmet need."

The therapy received its first regulatory approval in November 2015 when it was ratified by the US Food and Drug Administration.

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