Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to lenalidomide for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.

This is written in the approval document as:

REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.

Citation

Bristol-Myers Squibb Company. Revlimid (lenalidomide) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021880s067lbl.pdf. Revised March 2023. Accessed October 30, 2024.

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Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (1) 5q deletion Myelodysplastic Syndromes Lenalidomide