Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized lenalidomide for the treatment of adult patients with transfusion-dependent anaemia due to low- or intermdeiate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

This is written in the approval document as:

Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

Citation

Bristol-Myers Squibb Pharma EEIG. Revlimid (lenalidomide) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf. Revised January 2024. Accessed March 28, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	5q deletion	Myeloproliferative Neoplasm	Lenalidomide