Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized imatinib for the treatment of adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor (PDGFR) gene rearrangements.
This is written in the approval document as:
Glivec is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Citation
Novartis Europharm Limited. Glivec (imatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf. Revised November 2023. Accessed March 7, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | PDGFRA rearrangements | Myelodysplastic Syndromes | Imatinib | |
| Sensitivity (+) | PDGFRB rearrangements | Myelodysplastic Syndromes | Imatinib | |
| Sensitivity (+) | PDGFRA rearrangements | Myeloproliferative Neoplasm | Imatinib | |
| Sensitivity (+) | PDGFRB rearrangements | Myeloproliferative Neoplasm | Imatinib |