Itovebi® (inavolisib) marks milestone as the first breast cancer treatment funded through Ontario's new faster access program

• Ontario's FAST program aims to speed up access to breakthrough cancer drugs for patients by almost a full year sooner.¹
• Itovebi offers a targeted treatment for advanced HR-positive, HER2-negative breast cancer with a PIK3CA mutation, following recurrence on or after completing adjuvant endocrine treatment. This mutation is found in approximately 40 per cent of HR-positive breast cancers and is generally associated with poor outcomes.^2,3,4

MISSISSAUGA, ON, Feb. 24, 2026 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Itovebi® (inavolisib) is the first breast cancer therapy funded through Ontario's new Funding Accelerated for Specific Treatments (FAST) program. This first-in-Canada initiative was designed to bridge the gap between drug approval and public availability, connecting patients to treatments up to a full year sooner.¹

Itovebi, in combination with palbociclib and fulvestrant, is used to treat adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine treatment.⁴

Breast cancer is the second leading cause of death from cancer in Canadian women.⁵ HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70 per cent of cases.^6,7 Study results showed the Itovebi treatment regimen more than doubled median progression-free survival (15 vs. 7.3 months) in the target patient population compared to the combination of palbociclib and fulvestrant alone.^8,9

The Canada's Drug Agency issued a final positive recommendation for the treatment on December 15, 2025.¹⁰ Roche Canada is committed to working with all jurisdictions and the pan-Canadian Pharmaceutical Alliance (pCPA) to ensure patients outside of Ontario can also access Itovebi as soon as possible following successful negotiations.

Quotes:
"For every Ontarian facing a cancer diagnosis, timely access to high-quality treatment can make all the difference. Through the FAST program, our government is accelerating access to life-saving therapies, including Itovebi, bringing hope, peace of mind, and transformative care to those who need it most."

Sylvia Jones, Deputy Premier and Minister of Health

"Ontario's FAST program marks an important step forward in patient-centred care by providing faster access to new cancer treatments like Itovebi for patients in need. Roche Canada applauds the province's leadership in accelerating access to innovative medicines and setting a strong example for the rest of Canada. By fostering bold collaboration across industry, governments, patients, and healthcare professionals, we have the opportunity to improve healthcare outcomes and ultimately ensure the right treatment gets to the right patient at the right time."

- Brigitte Nolet, President & CEO, Roche Canada Pharma

"Timely access to effective therapies is critical. Ontario's FAST program decision to fund Itovebi represents real progress for people living with HR-positive breast cancer, helping ensure patients and their care teams can access new treatment options without unnecessary delay. This decision reflects the importance of a responsive health-care system that keeps pace with scientific progress and the needs of patients."

-          Kimberly Carson, CEO of Breast Cancer Canada

"For patients and families facing cancer, time matters. We are encouraged to see Itovebi as one of the first breast cancer therapies to move through Ontario's FAST program, and we applaud the province's leadership in recognizing the urgent access needs that patients face every day. Faster access to innovative therapies can make a real difference in outcomes and quality of life. We hope this patient-focused approach inspires other provinces to follow suit, so people across Canada can access promising cancer treatments sooner, no matter where they live."

- MJ DeCoteau, Founder and Executive Director of Rethink Breast Cancer

"The approval of Itovebi through Ontario's FAST program represents a major milestone in timely access to breast cancer therapies. This treatment provides people diagnosed with metastatic, HR+ PIK3CA mutated breast cancer with a targeted option for their disease. We celebrate this decision and the precedent it sets for advancing access to much-needed treatment options for individuals diagnosed with breast cancer."

 - Cathy Ammendolea, Board Chair of Canadian Breast Cancer Network

About Itovebi (inavolisib)
Itovebi is an oral, targeted treatment for people with PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer. Itovebi is a selective inhibitor of phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) and also leads to the degradation of mutated p110α (encoded by the PIK3CA gene). In PIK3CA-mutated breast cancer xenograft models, Itovebi reduced tumor growth, which increased when combined with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib and the endocrine therapy fulvestrant, as compared to any treatment alone or in doublet combinations.

About hormone receptor (HR)-positive breast cancer
HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.^6,7 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to one or both hormones – oestrogen or progesterone – which can contribute to tumour growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.^11,12,13 The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with CDK4/6 inhibitors.³

About Roche Canada
At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies.

With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and sustainable healthcare systems. We are committed to creating a world where we all have more time with the people we love.

And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries.

Having the courage to reinvent ourselves and question the status quo is what patients and healthcare systems expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs nearly 2,000 people at its offices in Mississauga, Ontario, in Laval, Quebec, and across the country from coast to coast to coast.

For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn.

All trademarks used or mentioned are the property of its respective owners.

References

1. Ontario Ministry of Health. News Release: Ontario Connecting Patients to Life-Saving Cancer Drugs Faster. Published online October 7, 2025. Available from: https://news.ontario.ca/en/release/1006579/ontario-connecting-patients-to-life-saving-cancer-drugs-faster
   
   
2. Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22:1002.
   
   
3. Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179.
   
   
4. Itovebi Product Monograph, February 14, 2025.
   
   
5. Canadian Cancer Society, Breast Cancer Statistics, May 2024. Available from: https://cancer.ca/en/cancer-information/cancer-types/breast/statistics
   
   
6. National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 January]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
   
   
7. Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.
   
   
8. Turner NC, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024;391(17):1584-1596. doi:10.1056/nejmoa2404625
   
   
9. Jhaveri KL, et al. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025;393(2):151-161. doi:10.1056/nejmoa2501796
   
   
10. CDA-AMC. Reimbursement Recommendation: Inavolisib (Itovebi).  Published online December 2025. Available from: https://www.cda-amc.ca/sites/default/files/DRR/2025/PC0382-Recommendation.pdf 
    
    
11. National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 January]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
    
    
12. Tomas R and Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20.
    
    
13. Galipeau N, et al. Understanding key symptoms, side effects, and impacts of HR+/HER- advanced breast cancer: qualitative study findings. J Patient-Rep Outcomes. 2019;3(1):10.

SOURCE Hoffmann-La Roche Limited (Roche Canada)

Media Contact: Jolinne Kearns, Communications Manager, Hoffmann-La Roche Limited (Roche Canada), 416-726-7699, [email protected]