Game-Changing News: Health Canada Approves KISQALI® to Help Prevent Recurrence in Early Breast Cancer

We’re here with some news of hope and progress—two things that every breast cancer patient and survivor needs more of. On behalf of the team at AskEllyn, we’re thrilled to share important news from Novartis Canada that could reshape what life looks like after an early breast cancer diagnosis.

Read the Novartis Canada press release here.

Health Canada has approved KISQALI® (ribociclib tablets) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) stage II or III early breast cancer (eBC) who are at high risk of recurrence.

This approval marks a turning point for thousands of Canadians navigating early breast cancer—and living with the worry that it might return.

@askellyn

@NOVARTIS has received #healthcanada approval for its #breastcancer drug #KISQALI which is shown to lower rate of recurrence when combined with an aromataseinhibitor. I cover this news on AskEllyn.ai

♬ original sound – askellyn

Why This Matters: The Risk of Metastatic Relapse Is Real

Even with early detection and aggressive treatment, many women and men with early-stage HR+/HER2- breast cancer live under a shadow of uncertainty.

  • 1 in 3 patients diagnosed with stage II
  • More than half of those with stage III

…will experience incurable metastatic relapse within 20 years of diagnosis—even if they’ve already received adjuvant endocrine therapy (ET), which has long been the standard of care.

Read Julie Rock’s account of her journey from breast cancer diagnosis to metastatic disease.

For too long, ET has been the only option for reducing recurrence in this population. But the statistics are clear: for those at high risk, ET alone may not be enough.

This is where KISQALI® enters the picture.

What’s New: KISQALI® + Hormone Therapy = A New Line of Defence

KISQALI® is a CDK4/6 inhibitor, a class of drugs that work by blocking proteins that promote cancer cell growth. Already widely used in metastatic settings, its expansion into early breast cancer is significant.

According to the pivotal NATALEE trial, when KISQALI® was added to hormone therapy, the risk of recurrence was reduced by 25%—across a broad population of patients with stage II or III HR+/HER2- breast cancer. That includes:

  • N0 high-risk to N3 patients
  • Women of all ages
  • Patients with or without lymph node involvement

The drug also showed a consistent 25% reduction in the risk of distant metastasis, when cancer spreads to other parts of the body, like the bones, liver, or lungs.

This is a first-of-its-kind approval in Canada for this population, offering a new option beyond hormone therapy alone for people who otherwise would have had no additional tools to prevent recurrence.

What This Means for Patients and Survivors

If you’re currently undergoing treatment for early-stage HR+/HER2- breast cancer—or supporting someone who is—this news offers real-world hope.

It also represents a new standard of care for many high-risk patients.

KISQALI® is now available in Canada, and with Health Canada’s approval, oncologists across the country can begin integrating it into treatment plans for appropriate patients.

At AskEllyn, we know that survivorship is not just about surviving—it’s about reducing fear, increasing options, and building a life beyond cancer. New treatments like KISQALI® do more than lower recurrence risk—they restore a sense of control and renewed confidence in the future.

A Step Toward More Personalized, Effective Care

This approval is also a testament to how far breast cancer research has come—and how science continues to push toward more personalized treatments based on stage, subtype, and individual risk.

Novartis’ commitment to addressing unmet needs in early breast cancer is evident in the rigorous science behind KISQALI® and its broader mission to change the course of breast cancer—not just treat it after it spreads.

Final Thoughts from AskEllyn

This is not just a medical update—it’s a moment of hope for countless women and families across Canada. 

We’ll be watching closely as KISQALI® becomes available and patients begin to benefit from this long-awaited advancement. And as always, we encourage you to:

  • Speak with your oncologist about new treatment options
  • Stay informed about clinical trial results
  • Advocate for access to the therapies that best suit your unique journey

The future of breast cancer care is changing—today, for the better.

With strength, solidarity, and science on our side, we move forward.


For more information on KISQALI®, talk to your healthcare provider or visit Novartis Canada’s official website.

Have a story about early breast cancer or recurrence prevention you’d like to share? Contact us. 

Ellyn’s take on this news here.

#TogetherWeAsk #BreastCancer #KISQALI #EarlyBreastCancer #HRPositive #HER2Negative #CDK46 #AskEllyn

Ellyn Winters Robinson

Ellyn Winters-Robinson is a breast cancer survivor, entrepreneur, author, in-demand speaker, women’s health advocate, professional communicator and a globally recognized health rebel. Ellyn's best-selling book "Flat Please Hold the Shame," is a girlfriend’s companion guide for those on the breast cancer journey. She is also the co-creator of AskEllyn.ai, the world’s first conversational AI companion for those on the breast cancer journey. With Dense Breasts Canada and award-winning photographer Hilary Gauld, Ellyn also co-produced I WANT YOU TO KNOW, a celebrated photo essay showing the diverse faces and stories of 31 individuals on the breast cancer journey. Ellyn’s story and AskEllyn.ai have been featured in People Magazine, Chatelaine Magazine, the Globe and Mail, CTV National News and Your Morning, and Fast Company.

You may also like