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These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020
Medication labelWhy this: Advisory · dailymed-prescription
GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. GAVRETO is indicated for the 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 [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- generic_name
- pralsetinib
- product_names
- Pralsetinib
- ndc
- 71332-006, 71332-006-60, 71332-006-90, 71332-006-12
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en