Health Canada Approves Amgen's New Multiple Myeloma Treatment Kyprolis (carfilzomib)
In the ASPIRE clinical trial Kyprolis demonstrated improved progression-free survival for relapsed patients1
MISSISSAUGA, ON, Jan. 28, 2016 /CNW/ - Amgen Canada Inc. today announced that Health Canada has approved Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy.1
In the ASPIRE clinical trial, on which the approval was based, the median progression-free survival (PFS) for patients receiving Kyprolis, lenalidomide, and low dose dexamethasone was 26.3 months (95 per cent CI: 23.3 to 30.5 months) vs. 17.6 months (95 per cent CI: 15.0 to 20.6 months) in the lenalidomide and low dose dexamethasone arm.1
Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting approximately 7,000 people in Canada.2 Nearly all patients with the disease experience periods of remission, followed by relapses and eventually their disease becomes resistant to treatment.
"While multiple myeloma survival has improved over time, the disease remains incurable and unfortunately all patients will eventually experience relapses and no longer respond to treatment," said Dr. Donna Reece, Professor and Director of the Program for Multiple Myeloma and Related Diseases in the Department of Medical Oncology and Hematology at Princess Margaret Hospital/University of Toronto. "As hematologist, I welcome the approval of Kyprolis as a new option for my patients."
"Although patient outcomes have significantly improved over the past decade thanks to new, innovative treatments, multiple myeloma remains an incurable cancer. The approval of Kyprolis represents an important step forward in our journey to transform this disease into a long-term, manageable condition," said Aldo Del Col, Co-founder and Chairman of Myeloma Canada. "We applaud Health Canada's decision to approve Kyprolis and are encouraged by the impact this new treatment will have on the lives of Canadian myeloma patients."
Due to the unmet need in this patient population, Kyprolis was granted a Priority Review by Health Canada for this new drug submission.
"Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing," said Dr. Clive Ward-Able, Executive Director, Research and Development, Amgen Canada Inc. "The approval of Kyprolis marks a step forward for the treatment of multiple myeloma patients."
About Multiple Myeloma
Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma and results from an abnormality of plasma cells, usually in the bone marrow.2,3 Worldwide, nearly 230,000 people are living with multiple myeloma, including approximately 7,000 in Canada seven new cases per day.2,4,5 Last year, an estimated 2,700 new cases were diagnosed and 1,400 people died from this cancer.6
About Kyprolis (carfilzomib)1
Kyprolis, also called carfilzomib, is a proteasome inhibitor. Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. Kyprolis blocks proteasomes, which can lead to an excessive build-up of proteins within cells. Kyprolis can cause cell death, especially in cancer cells because they are more likely to contain a higher amount of abnormal proteins. Kyprolis is administered in combination with lenalidomide and dexamethasone for the treatment of people with relapsed multiple myeloma and is indicated for use in patients who have received at one to three prior lines of therapy.
Important Safety Information Regarding Kyprolis (carfilzomib)1
- In the ASPIRE study (Study PX-171-009), which included 392 patients in the KRd arm:
- Most common adverse reactions (> 20 per cent in the KRd arm) include anemia, diarrhea, neutropenia, fatigue, thrombocytopenia, cough, pyrexia, upper respiratory tract infection, hypokalemia, muscle spasms, peripheral edema, nasopharyngitis and constipation.
- Most common serious adverse reactions reported in the KRd arm as compared with the Rd arm were pneumonia (5.6 vs. 4.4 per cent), pulmonary embolism (2.6 per cent vs. 1.8 per cent), deep vein thrombosis (2.3 per cent vs 1.5 per cent), and febrile neutropenia (2.0 per cent vs. 0.8 per cent).
- Most common adverse events leading to discontinuation of Kyprolis included pneumonia (1 per cent) myocardial infarction (0.8 per cent) and upper respiratory tract infection (0.8 per cent).
More information about adverse reactions may be found in the Kyprolis Product Monograph.
About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.
Forward-Looking Statements
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References:
1 Kyprolis Product Monograph. Amgen Canada Inc. (January 2016).
2 Myeloma Canada. Incidence and Prevalence in Canada. http://www.myelomacanada.ca/en/incidence_prevalence.htm. Accessed November 2015.
3 Canadian Cancer Society. What is multiple myeloma? http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/multiple-myeloma/?region=ab. Accessed November 2015.
4 Bray F, Ren JS, Masuyer E, Ferlay J. Estimates of global cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar. 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.
5 Myeloma Canada. About Myeloma. http://www.myelomacanada.ca/en/aboutmyeloma.htm Accessed January 2016.
6 Canadian Cancer Society. Multiple myeloma statistics. http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/statistics/?region=ab. Accessed November 2015.
SOURCE Amgen Canada
