Regulatory approval

Published by the Food and Drug Administration. Approved

GAVRETO is a kinase inhibitor indicated for treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).

This is written in the approval document.

Citation

Blueprint Medicines Corporation. Gavreto (pralsetinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213721s015lbl.pdf. Revised March 2024. Accessed October 30, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	v::RET	Non-Small Cell Lung Cancer	Pralsetinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2023-08-09	Food and Drug Administration	Indication received traditional approval.