Roche Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) have successfully completed negotiations for Itovebi® (inavolisib), a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

MISSISSAUGA, ON, June 23, 2026 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for Itovebi (inavolisib) on May 26, 2026. The pCPA negotiates on behalf of the provinces and territories, making the end of these negotiations a critical step in bringing Itovebi closer to public access across the country.

"Successfully concluding negotiations is the result of close collaboration with the pCPA, and we are grateful for their partnership in reaching this critical milestone," said Simon Yunger, Vice-President of Value, Pricing and Reimbursement. "We remain deeply motivated to work with all provinces and territories to bring Itovebi to Canadians living with advanced PIK3CA-mutated breast cancer – a population facing an aggressive disease traditionally associated with a poor prognosis – as swiftly as possible."

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.¹

Breast cancer is the second leading cause of death from cancer in Canadian women.² HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70 per cent of cases.^3,4 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. ^5,6

The successful conclusion of these negotiations occurred roughly five months after Canada's Drug Agency's (CDA-AMC) final positive recommendation and four months after it was funded in Ontario via the Funding Accelerated for Specific Treatments (FAST) program, underscoring the momentum behind this therapy. With this critical foundation in place, Roche Canada's priority is to support the remaining jurisdictions in finalizing their funding decisions to ensure eligible patients gain public access as quickly as possible.

About Itovebi (inavolisib)¹

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.^3,4 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.^3,4,7 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.⁸

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 a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. 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 the healthcare system 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 almost 2,000 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics division in Laval, Québec.

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. Itovebi Product Monograph, October 1, 2025.
2. Canadian Cancer Society, Breast Cancer Statistics, May 2024. Available from: https://cancer.ca/en/cancer-information/cancer-types/breast/statistics
3. 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.
4. Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.
5. 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
6. 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
7. 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.
8. 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.

SOURCE Hoffmann-La Roche Limited (Roche Canada)

Jolinne Kearns, Communications Manager, Roche Canada, 416-726-7699, [email protected]