Healthcare Industry News:  ixazomib 

Biopharmaceuticals Oncology Regulatory

 News Release - August 8, 2016

Takeda Receives Marketing Authorization in Canada for NINLARO(TM) (ixazomib) in Relapsed/Refractory Multiple Myeloma

CAMBRIDGE, Mass. & OSAKA, Japan--(Healthcare Sales & Marketing Network)--Takeda Pharmaceutical Company Limited (TSE:4502) today 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.

About NINLAROTM (ixazomib) capsules

NINLAROTM (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 U.S. Food and Drug Administration (FDA) in November 2015 following a priority review. In the U.S., 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 U.S. 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 systemic light-chain (AL) amyloidosis, a related ultra orphan disease, in 2014.

The comprehensive ixazomib clinical development program, TOURMALINE, further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. TOURMALINE includes a total of five ongoing pivotal trials – four investigating every major multiple myeloma patient population and one in 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
In addition to the TOURMALINE program, ixazomib is being evaluated in the various therapeutic combinations for various patient populations in investigator initiated studies globally.

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 monoclonal plasma cells, or myeloma cells, becomes cancerous and multiplies. These malignant plasma cells 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 anemia. Multiple myeloma is a rare form of cancer. In Canada, it is estimated that approximately 7,500 people live with multiple myeloma and there are 114,000 new cases globally per year.


Source: Takeda Pharmaceutical

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