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PIQRAY® is approved and now available in Canada as the first and only treatment specifically for patients with a PIK3CA muta

PIQRAY® is approved and now available in Canada as the first and only treatment specifically for patients with a PIK3CA mutation in HR-positive, HER2-negative advanced breast cancer

Canada NewsWire

Approval is based on results from SOLAR-1, where PIQRAY® in combination with fulvestrant nearly doubled median progression-free survival (PFS) compared to fulvestrant alone

  • Breast cancer is the most common cancer in Canadian women.1 
  • While overall 5-year survival rates for female breast cancer are relatively high at 87%, women with metastatic breast cancer face a 22% survival rate over 5 years.2
  • Approximately 40% of patients with HR-positive, HER2-negative advanced breast cancer may face worse disease prognosis due to the presence of PIK3CA mutations in their tumours.3-9

DORVAL, QC, Aug. 13, 2020 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that PIQRAY® (alpelisib) is approved and now available in Canada. PIQRAY® in combination with fulvestrant is indicated for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.10 This approval marks the first-ever treatment specifically for HR-positive, HER2-negative metastatic breast cancer with a PIK3CA mutation and is based on results from the pivotal SOLAR-1 clinical trial, which included ten Canadian trial sites and ten Canadian investigators.

For women living with metastatic breast cancer, also known as Stage IV breast cancer, the cancer has spread beyond the breast to other areas of the body, such as the lungs, liver, bones or brain.11 It may happen before or after treatment, or it may develop from reoccurring breast cancer.12 While there have been advancements in early detection and treatment, there is still no cure for metastatic breast cancer.13 Men are also affected by breast cancer, representing over 200 new cases in Canada per year.14

"For Canadian patients living with metastatic breast cancer and this particular mutation, the arrival of alpelisib as a new therapeutic option is promising news because it allows us to offer more treatment options and tailor treatment accordingly," said Dr. Jan-Willem Henning, Medical Oncologist, Tom Baker Cancer Centre, and Clinical Assistant Professor, Cumming School of Medicine, University of Calgary. "This is expected to change the way we practise medicine in this area."

PIK3CA is the most commonly mutated gene in HR-positive, HER2-negative breast cancer; approximately 40% of patients living with HR-positive, HER2-negative breast cancer have this mutation.3,4 PIK3CA mutations are associated with tumour growth, resistance to endocrine treatment and a poor overall prognosis.5,6

A commercial companion diagnostic for PIK3CA mutation testing is already available, and Novartis is working to set up PIK3CA mutation testing Centres of Excellence to make this validated diagnostic testing more widely available to Canadians.

"For the first time, patients can be tested for the PIK3CA biomarker and receive a treatment plan based on their specific type of genetic mutation," said Cathy Ammendolea, Chair of the Board of Directors, Canadian Breast Cancer Network. "This represents an important milestone, offering new hope to Canadian patients living with metastatic breast cancer, and we look forward to the impact it will have."

PIQRAY® belongs to a family of medications called kinase inhibitors.10 PIQRAY® is used with another anti-cancer medication called fulvestrant, an estrogen receptor antagonist.10 Estrogen receptor antagonists or blockers attach directly to and block the estrogen receptors on cancer cells so that the cancer cells can't use estrogen.15 When given together with fulvestrant, PIQRAY® may stop certain breast cancer cells from dividing and growing.10

In the Phase III results from SOLAR-1, PIQRAY® plus fulvestrant demonstrated statistically significant median progression-free survival (PFS) (11.0 months) in HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation compared to fulvestrant alone (5.7 months), HR=0.65, 95% CI: 0.50-0.85, p<0.001.16 The overall response rate (ORR), an indicator of the proportion of patients who experience at least a 30% reduction in overall tumour size, was 35.7% for patients with a PIK3CA mutation who received the PIQRAY®-fulvestrant combination (95% CI: 27.4-44.7) and 16.2% for those who received fulvestrant alone (95% CI: 10.4-23.5) (p=0.0002).16,17

"At Novartis, we are at the forefront of driving scientific advancements and are proud of our leadership in breast cancer for more than two decades," said Daniel Hébert, Vice-President, Medical Affairs, Oncology, Novartis Pharmaceuticals Canada Inc. "The data from this Phase III trial that led to the approval of PIQRAY® in breast cancer is impressive, and we are pleased to offer a treatment that targets the PIK3CA mutation specifically."

With one of the most diverse breast cancer pipelines and the largest number of breast cancer compounds in development, Novartis leads the industry in the discovery of new therapies and combinations, especially in HR-positive breast cancer, the most common form of the disease.

About PIQRAY® (alpelisib)

PIQRAY® is an inhibitor of phosphatidylinositol3kinase (PI3K) with inhibitory activity predominantly against the PI3K-alpha isoform, called PIK3CA mutations. These mutations are associated with resistance to endocrine therapy, disease progression and a poor prognosis. PIQRAY® was developed by the Novartis Institutes for BioMedical Research (NIBR).

About Novartis in Advanced Breast Cancer

Novartis tackles breast cancer with advanced science, collaboration and a passion for transforming patient care. We've taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.

About Novartis Pharmaceuticals Canada Inc.

Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2019, the company invested $51.8 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,500 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult   

PIQRAY is a registered trademark.


  1. World Health Organization. Cancer Population Fact Sheet – Canada. Available at: Accessed on June 7, 2020.
  2. Canadian Cancer Society. Canadian Cancer Statistics, a 2018 special report on cancer incidence by stage. Available at: Accessed on June 7, 2020.
  3. The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70.
  4. Sabine V, et al. Mutational analysis of PI3K/AKT signaling pathway in tamoxifen exemestane adjuvant multinational pathology study. Journal of Clinical Oncology. 2014;32:2951-8.
  5. Miller TW, et al. Mutations in the Phosphatidylinositol 3-Kinase Pathway: Role in Tumor Progression and Therapeutic Implications in Breast Cancer. Breast Cancer Res. 2011;13:224.
  6. Saal LH, et al. Poor prognosis in carcinoma is associated with a gene expression signature of aberrant PTEN tumor suppressor pathway activity. PNAS 2007;104(18):7564-9.
  7. Tolaney S, et al. Presented at: 2019 American Association for Cancer Research (AACR) Annual Meeting; March 29-April 3, 2019; Atlanta, GA.
  8. Aleskandarany MA, et al. PIK3CA expression in invasive breast cancer: a biomarker of poor prognosis. Breast Cancer Res Treat. 2010;122(1):45-53.
  9. Sobhani N, et al. The prognostic value of PI3K mutational status in breast cancer: a meta-analysis. J Cell Biochem. 2018;119(6):4287-92.
  10. PIQRAY®, Product Monograph, March 11, 2020. Available at: Accessed on June 7, 2020.
  11. Canadian Cancer Society. What is Metastatic Cancer? Available at: Accessed on June 7, 2020.
  12. Canadian Breast Cancer Network. What is Metastatic Breast Cancer? Available at: Accessed on June 7, 2020.
  13. Canadian Breast Cancer Network and Rethink Breast Cancer. Living with Metastatic Breast Cancer in Canada. Available at: Accessed on March 5, 2020. Accessed on June 7, 2020.
  14. Canadian Cancer Society. Breast Cancer in Men. Available at: Accessed on June 7, 2020.
  15. Canadian Cancer Society. Hormonal Therapy for Breast Cancer. Available at: Accessed on June 7, 2020.
  16. André F, et al. Alpelisib for PIK3CA-Mutated, Hormone-Receptor-Positive Advanced Breast Cancer. N Eng J Med 2019.
  17. André F, et al. Alpelisib (ALP) + fulvestrant (FUL) for advanced breast cancer (ABC): Results of the phase III SOLAR-1 trial. Annals of Oncology, Vol 29, Suppl 8, October 2018, Abstract LBA3_PR.

SOURCE Novartis Pharmaceuticals Canada Inc.

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