Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that 5q deletion status confers therapeutic sensitivity to Lenalidomide in patients with Myelodysplastic Syndromes.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. Bristol-Myers Squibb Company. Revlimid (lenalidomide) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021880lbl.pdf. Revised December 2005. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2005-12-27	Food and Drug Administration	Indication received traditional approval.