Industry braces for updated access pathways
Health Canada has authorized four therapies across infectious disease, oncology, and hematology, broadening treatment options for patients in multiple categories. The recent approvals involve Pfizer-BioNTech, Bristol Myers Squibb, Bayer, and Roche Canada.
Updated COVID-19 vaccine
Pfizer Canada ULC and BioNTech SE received authorization for the LP.8.1 variant-adapted Comirnaty COVID-19 vaccine for individuals aged six months and older. The updated vaccine, targeting the Omicron LP.8.1 lineage, will be distributed in pharmacies this fall under provincial eligibility programs. The companies said discussions with private insurers and payers are ongoing to improve reimbursement options for those outside public programs.
Health Canada’s decision draws on previously submitted clinical, non-clinical, and real-world data. BioNTech holds the marketing authorization for Comirnaty and its adapted vaccines in multiple jurisdictions, including Canada.
Dual immunotherapy for gastrointestinal cancers
Bristol Myers Squibb Canada obtained approval for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for first-line treatment of two patient groups: adults with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer, and those with unresectable or advanced hepatocellular carcinoma.
The approvals are supported by Phase 3 CheckMate trials. In colorectal cancer, the regimen reduced the risk of disease progression or death by 79% compared to chemotherapy. In hepatocellular carcinoma, the combination demonstrated a survival benefit versus tyrosine kinase inhibitors.
Clinicians and patient organizations noted the potential treatment impact for cancers that account for significant mortality rates in Canada.
Prostate cancer therapy authorization
Bayer Inc. received marketing authorization for Nubeqa (darolutamide) in combination with androgen-deprivation therapy (ADT) for metastatic castration-sensitive prostate cancer (mCSPC). The approval is based on the Phase 3 ARANOTE trial, which showed a 46% reduction in risk of radiological progression or death compared with placebo plus ADT.
With this approval, darolutamide plus ADT becomes the first androgen receptor inhibitor in Canada approved for mCSPC, with or without docetaxel. Darolutamide is already authorized for patients with non-metastatic castration-resistant prostate cancer at high risk of metastasis.
Lymphoma treatment expansion
Hoffmann-La Roche Limited secured authorization for Columvi (glofitamab) combined with gemcitabine and oxaliplatin (GemOx) for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant.
The decision is supported by the Phase 3 STARGLO study, which showed a 41% reduction in the risk of death versus Rituxan plus GemOx and a complete response rate of 58.5% compared with 25.3% for the comparator arm.
DLBCL accounts for up to 40% of non-Hodgkin lymphoma cases in Canada, with many patients facing limited options after first-line treatment. Roche said it will work with public and private plans to support timely access.
