Hoffmann-La Roche Limited (Roche Canada) announced the successful completion of negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for Itovebi (inavolisib) on May 26, 2026. The pCPA negotiates on behalf of Canadian provinces and territories, making this a critical step toward public access across the country for patients with advanced hormone receptor-positive, HER2-negative breast cancer harboring a PIK3CA mutation.
Negotiation Milestone and Next Steps
“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 at Roche Canada. “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.”
The successful conclusion occurred roughly five months after Canada’s Drug Agency’s (CDA-AMC) final positive recommendation and four months after Ontario funded Itovebi via the Funding Accelerated for Specific Treatments (FAST) program. Roche Canada’s priority is now to support remaining jurisdictions in finalizing their funding decisions to ensure eligible patients gain public access quickly.
Clinical Efficacy and Disease Context
Itovebi, in combination with palbociclib and fulvestrant, is indicated for 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. Breast cancer is the second leading cause of cancer death in Canadian women, with HR-positive breast cancer accounting for approximately 70% of all cases. Study results showed the Itovebi regimen more than doubled median progression-free survival (15 months vs. 7.3 months) compared to palbociclib and fulvestrant alone.
About Itovebi (inavolisib)
Itovebi is an oral, targeted treatment that selectively inhibits phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) and leads to degradation of mutated p110α (encoded by the PIK3CA gene). In PIK3CA-mutated breast cancer xenograft models, Itovebi reduced tumor growth, with enhanced effects when combined with the CDK4/6 inhibitor palbociclib and the endocrine therapy fulvestrant compared to any treatment alone or in doublet combinations.
