Regulatory approval

Published by the European Medicines Agency. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	5q deletion	Myeloproliferative Neoplasm	Lenalidomide

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2013-06-13	European Medicines Agency	Indication received approval from the European Commission.