Itovebi® (inavolisib) now publicly funded in Quebec for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation following unanimous recognition of therapeutic value by INESSS

• Itovebi is now included on the Quebec List of Medications (RAMQ), marking the latest milestone for Itovebi towards public access.¹

MISSISSAUGA, ON, Aug. 11, 2026 /CNW/ -- Hoffmann-La Roche Limited (Roche Canada) is pleased to share that following unanimous therapeutic value recognition from the Institut national d'excellence en santé et en services sociaux (INESSS) and successful negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA), Itovebi has been added to the Régie de l'assurance maladie du Québec (RAMQ) List of Medications for eligible patients with advanced HR-positive, HER2-negative breast cancer with a PIK3CA mutation, effective June 25, 2026, in accordance with specific clinical criteria.^1,2,3

This listing was based on the INAVO120 study results which 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.^4,8,9  In addition, treatment with Itovebi, in combination with palbociclib and fulvestrant, demonstrated a statistically significant and clinically meaningful improvement in overall survival, with a 33% relative reduction in the risk of death.^4,9

"Ensuring fast, sustainable access to innovative cancer therapies requires strong health system collaboration," said Simon Yunger, Vice-President, Value, Pricing and Reimbursement, Roche Canada. "Working alongside INESSS and health authorities to make Itovebi widely available across Quebec reflects our shared commitment to advancing care and improving outcomes for patients facing this aggressive form of breast cancer."

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

Roche Canada welcomes the expediency with which Itovebi was made available for people living in Quebec with advanced breast cancer. Following this key milestone, our focus remains on continued collaboration with provincial and territorial drug plans to establish broad public access for eligible patients nationwide.

About Itovebi (inavolisib)⁴
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. This reduction 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.

For important safety information-including warnings and precautions, adverse reactions, and dosing guidelines, please consult the Itovebi Product Monograph at https://go.roche.com/itovebi_pm

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.^6,7,10  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.¹¹

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. Régie de l'assurance maladie du Québec (RAMQ). Liste des médicaments [PDF document]. June 25, 2026: p. 152. Available from: https://www.ramq.gouv.qc.ca/sites/default/files/documents/non_indexes/liste-med-2026-06-25-fr.pdf
2. Institut national d'excellence en santé et en services sociaux (INESSS). Extrait d'avis au ministre : ItovebiMC – Cancer du sein localement avancé ou métastatique présentant un variant pathogène PIK3CA [PDF document]. Published March 2026. Available from: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Avril_2026/Avis_20260316/Itovebi_2026_03.pdf
3. pan-Canadian Pharmaceutical Alliance (pCPA). Inavolisib (Itovebi) Negotiation Status [File #76743]. Published May 26, 2026. Available from: https://pcpa-app.ca/browse-negotiations/76743
4. Itovebi Product Monograph, July 16, 2026. Available at: https://assets.roche.com/f/173850/x/a5ae9810d3/itovebi_pm_e.pdf
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. 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.
11. 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)

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