Gavreto (pralsetinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

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

Indication	Statements
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).	1
GAVRETO is a kinase inhibitor indicated for treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).	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
Sensitivity (+)	v::RET	Papillary Thyroid Cancer	Pralsetinib