ALYFTREK, Blenrep, and KEYTRUDA approvals may shift coverage strategies across Canadian pharmaceutical plans
Three newly approved therapies in Canada target high-cost conditions and could shift the landscape for private and public drug plan coverage.
Health Canada has approved Merck’s KEYTRUDA (pembrolizumab) in combination with chemoradiotherapy (CRT) as a treatment for FIGO 2014 Stage III–IVA cervical cancer, marking its first approved indication in Canada with CRT, as reported by Merck on July 25.
The approval is based on the Phase 3 KEYNOTE-A18 trial, which showed statistically significant improvements in both progression-free and overall survival versus CRT with placebo.
Shannon Salvador, gynecologic oncologist at the Jewish General Hospital and president of the Society of Gynecologic Oncology of Canada, said the approval “adds another therapeutic option for patients in an important disease space” and noted its statistical significance in survival outcomes.
André Galarneau, executive director and vice president of Merck Canada’s Oncology Business Unit, called it “a pivotal moment,” highlighting the potential to expand treatment access.
Separately, Health Canada granted approval to GSK’s Blenrep (belantamab mafodotin for injection) in two new combinations for adults with relapsed or refractory multiple myeloma, as per GSK’s July 25 announcement.
The new indications include use with bortezomib and dexamethasone, or pomalidomide and dexamethasone, after at least one prior therapy including lenalidomide.
The decision is supported by the Phase III DREAMM-7 and DREAMM-8 trials, which showed statistically significant and clinically meaningful improvements in progression-free survival versus standard of care, and overall survival in DREAMM-7.
According to GSK, Blenrep is the only anti-BCMA antibody-drug conjugate approved in Canada, offering a differentiated mechanism of action and does not require pre-administration regimens or hospitalisation.
Michelle Horn, country medical head at GSK Canada, said Blenrep “has been shown to extend survival and remission,” while Myeloma Canada CEO Martine Elias noted the role of diverse treatment options in “prolonging remission and enhancing survival outcomes.”
The most common adverse reactions, reported in 20 percent or more of patients, included visual changes, fatigue, infection, and neuropathy.
Eye-related effects were managed with dose spacing and reductions and resulted in low discontinuation rates (≤9 percent).
In cystic fibrosis, Vertex Pharmaceuticals’ ALYFTREKTM (vanzacaftor/tezacaftor/deutivacaftor) also received Health Canada approval for patients aged 6 and older who have at least one F508del mutation or another responsive mutation in the CFTR gene, as reported by Vertex on July 25.
ALYFTREK is the first once-daily CFTR modulator and introduces a potential treatment option for up to 60 Canadians who were previously ineligible.
It may also impact approximately 3,800 individuals already using CFTR modulators due to its simplified administration with fat-containing food.
Michael Siauw, general manager at Vertex Pharmaceuticals Canada, said the therapy expands eligibility to 114 additional mutations and “brings us one step closer” to broader CFTR function restoration.
The Health Canada decision follows global Phase 3 trials across more than 20 countries and 200 sites.
Among patients aged 12 and older, the trials met their primary endpoint (non-inferiority to TRIKAFTA on absolute ppFEV1 change) and all key secondary endpoints, including sweat chloride levels.
For children aged 6–11, the study demonstrated safety and benefits in respiratory function and sweat chloride.
Bradley Quon, medical and research director at St. Paul’s Hospital’s Adult Cystic Fibrosis Program, highlighted the once-a-day dosing as potentially lowering treatment burden while improving CFTR function.
