Canadian approval for Takeda's Ninlaro

8 August 2016

Takeda Pharmaceutical (TYO: 4502), Japan’s largest drugmaker, has received approval from medicines regulator Health Canada for Ninlaro (ixazomib) capsules in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

In Canada, it is estimated that around 7,500 people live with multiple myeloma. The approval was primarily based on the results of the final analysis of the pivotal Phase III trial, TOURMALINE-MM1, which demonstrated that Ninlaro in combination with lenalidomide and dexamethasone significantly extended progression-free survival, with a manageable safety profile in patients with relapsed/refractory multiple myeloma. Due to the high unmet need in multiple myeloma, the New Drug Submission for Ninlaro was granted a Priority Review by Health Canada.

Already approved in USA

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