Gavreto FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 22, 2023.
FDA Approved: Yes (First approved September 4, 2020)
Brand name: Gavreto
Generic name: pralsetinib
Dosage form: Capsules
Company: Genentech, Inc.
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer
Gavreto (pralsetinib) is an oral selective RET kinase inhibitor used for the treatment of rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC), and RET-mutant medullary thyroid cancer (MTC).
- Gavreto is indicated 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).
- 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).
Development timeline for Gavreto
Further information
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