Health Canada grants marketing approval for Takeda’s multiple myeloma treatment

9 August 2016 (Last Updated August 9th, 2016 18:30)

Health Canada has approved Japanese-based Takeda Pharmaceutical Company’s Ninlaro (ixazomib) capsules, in combination with lenalidomide and dexamethasone, to treat patients with multiple myeloma (MM).

Health Canada has approved Japanese-based Takeda Pharmaceutical Company’s Ninlaro (ixazomib) capsules, in combination with lenalidomide and dexamethasone, to treat patients with multiple myeloma (MM).

Oral proteasome inhibitor Ninlaro, in combination with lenalidomide and dexamethasone, is used to treat adult patients affected with MM and who have received at least one prior therapy.

MM is a cancer of the plasma cells found in bone marrow. In the case of MM, a group of monoclonal plasma cells, or myeloma cells, becomes cancerous and multiplies.

The Health Canada approval was based on the results of the final analysis of the major Phase III trial, Tourmaline-MM1.

The trial revealed that Ninlaro, in combination with lenalidomide and dexamethasone, can significantly extend progression-free survival, with a manageable safety profile in patients with relapsed / refractory MM.

Takeda Canada general manager Chatrick Paul said: “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.

"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 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.”

The new drug submission for Takeda’s Ninlaro was granted a priority review by Health Canada because of the high unmet need in the treatment of MM patients.

Marketing applications for Ninlaro are currently under review by several regulatory authorities across the globe.


Image: Micrograph of multiple myeloma. Photo: courtesy of Nephron.