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 |