Gavreto (pralsetinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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 November 2023. Accessed March 7, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::RET	Non-Small Cell Lung Cancer	Pralsetinib