Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized vandetanib for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Vandetanib is indicated in adults, children, and adolescents aged 5 years and older.
This is written in the approval document as:
Caprelsa is indicated for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older.
Citation
Sanofi B.V. Caprelsa (vandetanib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/caprelsa-epar-product-information_en.pdf. Revised August 2023. Accessed March 6, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.Type | Biomarker(s) | Cancer type | Therapy(ies) | |
---|---|---|---|---|
Sensitivity (+) | v::RET | Medullary Thyroid Cancer | Vandetanib |