Regulatory approval

Published by the European Medicines Agency. Withdrawn

Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

This is written in the approval document.

Citation

Roche Registration GmbH. Gavreto (pralsetinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/gavreto-epar-product-information_en.pdf. Revised January 2025. Accessed August 29, 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies

Contributions

Date	Contributor	Description
2025-08-29	Van Allen lab	On 2024-10-24, the European Commission withdrew the market authorization for Gavreto (pralsetinib) in the European Union at the request of the marketing authorization holder, Blueprint Medicines (Netherlands) B.V., due to their decision to permanently discontinue the marketing of the product for commercial reasons.
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-11-18	European Medicines Agency	Indication received approval from the European Commission.