Therapeutic Response Statement (Sensitivity)

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 U.S. Food and Drug Administration granted approval to pralsetinib for the 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 statement is based on a regulatory approval from the Food and Drug Administration:

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).

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. Blueprint Medicines Corporation. Gavreto (pralsetinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s009lbl.pdf. Revised August 2023. Accessed October 6, 2026.

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.