Regulatory approval

Published by the European Medicines Agency.

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 is written in the approval document as:

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 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 (+)	v::RET	Non-Small Cell Lung Cancer	Pralsetinib