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Drug Approval Updates

Health Canada Approvals and Provincial Drug Funding Decisions

In 2016, Health Canada approved four new drugs for the treatment of myeloma, more than have been approved over the past ten years. Health Canada approval, however, is only the first step in the long process of securing provincial funding for public drug programs.

Health Canada Approvals

  • Kyprolis® (carfilzomib): January 15, 2016
  • Empliciti ® (elotuzumab): June 21, 2016 (Manufacturer will not make the drug available in Canada at this time)
  • Darzalex ® (daratumumab): June 29,2016
  • Ninlaro ® (ixazomib): August 8, 2016
  • As of january 24, 2017, Health Canada has approved Revlimid® plus dexamethasone as a first-line treatment for newly diagnosed patients with multiple myeloma, not eligible for transplant
  • On April 17, 2017 Health Canada has approved Darzalex® (daratumumab), in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy

Provincial Drug Funding Announcements

  • In March 2016, Pomalyst® (pomalidomide) in combination with dexamethasone as third-line therapy and beyond for patients with multiple myeloma was approved for reimbursement on the Régie de l’assuance maladie du Québec (RAMQ)
  • On October 18, 2016, Alberta Health Services announced that Revlimid® is now funded as a first line treatment in patients with multiple myeloma who are not eligible for an autologous stem cell transplant. Criteria are as follow: Treatment should be in combination with dexamethasone for patients with *ECOG PS < 2 and until disease progression.
  • As of October 26, 2016,  The Saskatchewan Cancer Agency announced that Revlimid® is now funded as a first line treatment for patients with multiple myeloma who are not eligible for an autologous stem cell transplantat. Criteria are as follow: Treatment must be given is in combination with dexamethasone for patients with an ECOG performance status of less than or equal to 2 and continued until disease progression.
  • On November 8, 2016, the Yukon drug plan announced that Revlimid® is now funded as a first line treatment for patients with multiple myeloma who are not eligible for an autologous stem cell transplantat. Criteria are as follow: Any newly diagnosed multiple myeloma patient as an option for first line treatment who are not eligible for an autologous stem-cell transplant. Treatment should be in combination with dexamethasone for patients with an ECOG performance status less than or equal to 2 and continued until disease progression.
  • On December 1, 2016, Nova Scotia announced that Revlimid® is now funded as a first line treatment for patients with multiple myeloma who are not eligible for an autologous stem cell transplant. Criteria are as follow: Treatment should be in combination with dexamethasone for patients with ECOG performance status 0-2, and until disease progression.
  • Myeloma Canada is pleased to announce that as of March 24, 2017, the Ontario Public Drug Program has agreed to fund Revlimid ® (lenalidomide) as a first-line treatment for newly-diagnosed myeloma patients who are not eligible for high-dose chemotherapy (also known as autologous stem cell transplant).
  • On April 1, 2017, British Columbia also began provincially funding Revlimid ® as a first-line treatment for newly-diagnosed myeloma patients who are not eligible for high-dose chemotherapy. To view eligibility criteria for this indication, please click here.

*ECOG definition: ECOG Performance Status. These scales and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient and determine the appropriate treatment.

We would like to thank the patient and caregiver community who participated in Myeloma Canada’s advocacy efforts throughout the past year. By working together, we become stronger. By speaking as a unified voice for the Canadian myeloma community we have made a difference.