Health Canada Approves the First Oral Proteasome Inhibitor, Ninlaro

The first oral proteasome inhibitor was approved in the United States in November 2015. Now, the same product will be available to Canadians. Based on results from five studies called the TOURMALINE program, Health Canada has now approved Ninlaro™ in Canada. The approval is for the use of Ninlaro™ 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.

“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.”

The approval is based on results from TOURMALINE studies, which tested Ninlaro™ in four studies for multiple myeloma and one for light-chain amyloidosis:

• TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma

• TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma

• TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)

• TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT

• TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis

“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.”