Takeda Pharmaceutical Company Limited, a global, research and development-driven pharmaceutical company, announced Takeda Canada has received approval from 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 approximately 7,500 people live with multiple myeloma. The approval was primarily based on the results of the final analysis of the pivotal phase 3 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.

“Health Canada’s approval of Ninlaro represents an important step in Takeda’s unwavering commitment to combat cancer by delivering novel therapies to patients as quickly, effectively and safely as possible,” says Chatrick Paul, general manager at Takeda Canada. “We are one of the first countries in the world to gain marketing approval to deliver Ninlaro as a critical treatment option for multiple myeloma patients. We are pleased that Ninlaro – our first oncology prescription medicine in Canada – has a product label that is broad and robust, meaning Canadians living with relapsed/refractory multiple myeloma will now have a new effective treatment option available to them in the comfort of their home.”

“Multiple myeloma, a devastating diagnosis for patients and their families, is a complicated disease that requires effective treatment options,” said Dr. Donna Reece, Professor and Director of the Program for Multiple Myeloma and Related Diseases in the Department of Medical Oncology and Haematology at Princess Margaret Hospital/University of Toronto. “The approval of Ninlaro offers a much-needed new option for Canadian patients with multiple myeloma who have received at least one prior therapy. Its oral delivery may help multiple myeloma patients overcome some of the logistical burdens they may face with current therapies, which are typically administered in-clinic or in-hospital requiring significant travel and time constraints.”

Marketing applications for Ninlaro are currently under review by several regulatory authorities around the world.

Ninlaro (ixazomib) is an oral proteasome inhibitor which is also being studied in multiple myeloma and systemic light-chain (AL) amyloidosis. It was the first oral proteasome inhibitor to enter phase 3 clinical trials and to receive approval. Ninlaro was approved by the US Food and Drug Administration (FDA) in November 2015 following a priority review. In the US, Ninlaro is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.  

Ixazomib was granted orphan drug designation in multiple myeloma in both the US and Europe in 2011 and for AL amyloidosis in both the US and Europe in 2012. Ixazomib received Breakthrough Therapy status by the US FDA for relapsed or refractory systemic light-chain (AL) amyloidosis, a related ultra orphan disease, in 2014.