Health Canada announced the approval of Roche’s Columvi (glofitamab) for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and granted an additional marketing authorization for Bayer’s NUBEQA (darolutamide) in non-metastatic castration-resistant prostate cancer (nmCRPC).
Columvi’s Regulatory Milestone and Impact
Columvi, a bispecific antibody, secured approval for use in combination with gemcitabine and oxaliplatin (GemOx) in adults with R/R DLBCL who are not eligible for stem cell transplant. This marks the first bispecific antibody-based regimen available for these patients in Canada, a major advance for those with limited prognoses and few effective options. Clinical evidence from the Phase III STARGLO trial demonstrated a 41% reduction in risk of death and a 58.5% complete response rate with Columvi versus standard therapy, establishing a new benchmark for efficacy in this difficult-to-treat population.
DLBCL is the most common type of non-Hodgkin lymphoma, accounting for up to 40% of Canadian NHL cases. Despite initial treatments, a significant proportion of patients (approximately 40%) experience a relapse. Columvi’s outpatient administration and rapid availability are expected to improve access and transform outcomes, offering an alternative to CAR-T therapies, which require complex infrastructure and hospitalization.
NUBEQA’s Extended Indication
Meanwhile, Health Canada has granted an additional marketing authorization for NUBEQA. The new approval extends its use to patients with nmCRPC at high risk of developing metastasis. Supported by data from the ARAMIS study, NUBEQA (when added to androgen deprivation therapy) decreased the risk of disease progression or metastasis by 59% compared to placebo, with a favorable tolerability profile. The approval reflects data showing a median metastasis-free survival benefit of 22 months for patients receiving NUBEQA.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!