August 8, 2016
Takeda Pharmaceutical Company Limited has announced Takeda Canada has received approval from Health Canada for NINLARO™ (ixazomib) capsules in combination with lenalidomide and dexamethasone for treating adult patients with multiple myeloma who have received at least one prior therapy. It is estimated that approximately 7,500 people live with multiple myeloma in Canada. The approval was mainly based on the results of the final analysis of the pivotal Phase 3 trial, TOURMALINE-MM1. It demonstrated that NINLARO in combination with lenalidomide and dexamethasone extended progression-free survival significantly, with a manageable safety profile in patients with relapsed/refractory multiple myeloma.
Chatrick Paul, General Manager at Takeda Canada, 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 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. 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,” 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.