Therapeutic Response Statement (Sensitivity) Deprecated

This therapeutic response statement Supports the relationship that v::RET status confers therapeutic sensitivity to Pralsetinib in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized pralsetinib as a monotherapy treatment for adult patients with RET fusion-positive advanced non-small cell lung cancer (NSCLC) who have not previously been treated with a RET inhibitor.

This statement is based on a regulatory approval from the European Medicines Agency:

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.

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.

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.