Announcement comes as recent clin­i­cal results reveal ixazomib sig­nif­i­cantly extends pro­gres­sion-free survival for patients with re­lapsed / refractory multiple myeloma

Oakville, ON (Press Release) – The New Drug Submission (NDS) for Takeda’s ixazomib has been accepted for priority review by Health Canada. Ixazomib is the first inves­ti­ga­tional oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and/or refractory multiple myeloma. If approved, ixazomib will be the first oral pro­te­a­some inhibitor avail­able in Canada, helping meet the urgent needs of patients living with multiple myeloma, a dev­as­tat­ing, relapsing and incurable rare cancer. With once-weekly oral dosing, ixazomib enables the first all-oral triplet regi­men in­­clud­ing both a pro­te­a­some inhibitor and an immunomodulator for the treat­ment of re­lapsed and/or refractory multiple myeloma.

Health Canada may grant Priority Review status for drug sub­missions indicated for the treat­ment of a severely debilitating disease or con­di­tion wherein there exists an unmet medical need or for which a sub­stan­tial im­prove­ment in the benefit / risk profile of the ther­apy is dem­onstrated . On November 20, 2015, the U.S. Food and Drug Admin­istra­tion (FDA) approved the New Drug Application (NDA) for ixazomib capsules under Priority Review status. In July 2015, ixazomib was granted Accelerated Assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

“It is extremely encouraging to hear of Health Canada’s de­ci­sion to grant Priority Review of a new treat­ment option for multiple myeloma,” said Aldo Del Col, Co-founder and Chairman of the Board of Myeloma Canada. “For the many Canadians living with this incurable but in­creas­ingly treatable blood cancer, this news provides hope to patients for urgently-needed new treat­ment options that will in­­crease survival and provide a higher quality of life.”

The NDS for ixazomib was primarily based on the results of the final analysis of the pivotal Phase 3 trial, TOURMALINE-MM1. This study is an inter­na­tional, ran­dom­ized, double-blind, placebo controlled clin­i­cal trial of 722 patients designed to eval­u­ate the superiority of ixazomib plus lena­lido­mide and dexa­meth­a­sone over placebo plus lena­lido­mide and dexa­meth­a­sone in adult patients with re­lapsed and/or refractory multiple myeloma. Patients con­tinue to be treated to pro­gres­sion in this trial and will be eval­u­ated for long-term out­comes.

“It’s with great pleasure that we welcome Health Canada’s de­ci­sion to grant Priority Review for ixazomib. This is an im­por­tant devel­op­ment for Canadians living with multiple myeloma” said Chatrick Paul, General Manager at Takeda Canada. “Health Canada has clearly shown their commitment to Canadian patients living with complex and chal­leng­ing diseases.”

About Multiple Myeloma

Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of plasma cells, or myeloma cells, becomes can­cer­ous and multiplies, in­creas­ing the number of plasma cells to a higher than normal level. Because plasma cells circulate widely in the body, they have the poten­tial to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symp­toms in­­clud­ing bone pain and fatigue, a symp­tom of anaemia. Multiple myeloma is a rare form of cancer. In Canada, it is esti­mated that approx­i­mately 7,500 people live with multiple myeloma, with 2,700 new cases esti­mated to be diag­nosed in 2015 .

About Ixazomib

Ixazomib is an inves­ti­ga­tional oral pro­te­a­some inhibitor which is being studied in multiple myeloma, systemic light-chain (AL) amyloidosis, and other malig­nan­cies. Ixazomib was granted orphan drug desig­na­tion in multiple myeloma in both the United States and Europe in 2011 and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Break­through Therapy status by the U.S. FDA for re­lapsed or refractory AL amyloidosis in 2014. It is also the first oral pro­te­a­some inhibitor to enter Phase 3 clin­i­cal trials. There are cur­rently 22 Phase 3 clin­i­cal trial sites of ixazomib in Canada.

The TOURMALINE clin­i­cal devel­op­ment pro­gram further reinforces Takeda’s ongoing commitment to devel­op­ing inno­va­tive ther­a­pies for people living with multiple myeloma world­wide and the health­care professionals who treat them. Five global Phase 3 trials are ongoing:

• 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

In addi­tion to the TOURMALINE pro­gram, a large number of investigator ini­ti­ated studies are eval­u­ating ixazomib for patients globally.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global com­pany with its main focus on pharma­ceu­ticals. As the largest pharma­ceu­tical com­pany in Japan and one of the global leaders of the industry, Takeda is committed to strive to­wards better health for people world­wide through leading inno­va­t in medicine. Additional in­­for­ma­tion about Takeda is avail­able at takeda.com.

Takeda Canada, located in Oakville, Ontario, is the Canadian sales and market­ing organization of Takeda Pharma­ceu­tical Company Limited. Takeda Canada is transforming to become an agile specialty pharma­ceu­tical com­pany, focusing on gastroenterology and on­col­ogy, while continuing to meet a number of im­por­tant pri­mary care needs. Additional in­­for­ma­tion about Takeda Canada is avail­able at www.takedacanada.com.

Source: Takeda Canada.