Regulatory approval

Published by the Health Canada. Approved

REVLIMID (lenalidomide) is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Approval for this indication is based on red blood cell transfusion independence response rates. Overall survival benefit has not been demonstrated.

This is written in the approval document.

Citation

Bristol-Myers Squibb Canada. Revlimid (lenalidomide) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00074535.PDF. Published February 2024. Accessed June 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
HC (1) 5q deletion Myelodysplastic Syndromes Lenalidomide