Gavreto (pralsetinib) is a kinase inhibitor that is indicated for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) and for advanced or metastatic RET fusion positive thyroid cancer. Gavreto’s NSCLC approval is for adults, while its thyroid cancer approval includes patients 12 years old and older.
Medication Overview:
- Brand Name: Gavreto
- Generic Name: pralsetinib
- Treatment for: NSCLC, thyroid cancer
- Manufacturer: Rigel
- Initial FDA Approval: September 2020
Gavreto Indications Comparison Table
| Indicated Condition | Indication | Age | Date Approved |
|---|---|---|---|
| NSCLC | Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). | Adults | August 2023 |
| Thyroid Cancer | 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). | 12 years and older | December 2020 |
Warnings and Precautions:
- Serious Infections, including Opportunistic Infections: Monitor for signs and symptoms of infection and treat appropriately. Withhold, reduce the dose, or permanently discontinue Gavreto based on severity.
- Interstitial Lung Disease (ILD)/Pneumonitis: Withhold Gavreto for Grade 1 or 2 reactions until resolution and then resume at a reduced dose. Permanently discontinue for recurrent ILD/pneumonitis. Permanently discontinue for Grade 3 or 4 reactions.
- Hypertension: Do not initiate Gavreto in patients with uncontrolled hypertension. Optimize blood pressure (BP) prior to initiating Gavreto. Monitor BP after one week, at least monthly thereafter and as clinically indicated. Withhold, reduce dose, or permanently discontinue Gavreto based on severity.
- Hepatotoxicity: Monitor ALT and AST prior to initiating Gavreto, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose, or permanently discontinue Gavreto based on severity.
- Hemorrhagic Events: Permanently discontinue Gavreto in patients with severe or life-threatening hemorrhage.
- Tumor Lysis Syndrome: Closely monitor patients at risk and treat as clinically indicated.
- Risk of Impaired Wound Healing: Withhold Gavreto for at least five days prior to elective surgery. Do not administer for at least two weeks following major surgery and until adequate wound healing. The safety of resumption of Gavreto after resolution of wound healing complications has not been established.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception.
Dosage and Administration:
Select patients for treatment with Gavreto based on the presence of a RET gene fusion.
The recommended dosage in adults and pediatric patients 12 years and older is 400 mg orally once daily on an empty stomach (no food intake for at least two hours before and at least one hour after taking Gavreto).
Contraindications:
None.
Drug Interactions:
Strong or moderate CYP3A inhibitors and/or P-gp inhibitors: Avoid coadministration. If coadministration cannot be avoided, reduce the dose of Gavreto.
Strong or moderate CYP3A inducers: Avoid coadministration. If coadministration cannot be avoided, increase the dose of Gavreto.
Adverse Reactions:
The most common adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia and cough.
The most common Grade 3-4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium and increased bilirubin.
Examples of Pralsetinib in Guidelines
Therapy for Stage IV Non-Small-Cell Lung Cancer with Driver Alterations
- American Society of Clinical Oncology (ASCO), July 2025
- If selpercatinib is not available, clinicians may offer pralsetinib.
- If selpercatinib or pralsetinib are not available, clinicians may offer standard therapy following the non-driver alteration guideline.
Management of Patients with Anaplastic Thyroid Cancer
- American Thyroid Association (ATA), March 2021
- In NTRK or RET fusion ATC patients with stage IVC disease, the ATA suggests initiation of a TRK inhibitor (either larotrectinib or entrectinib) or RET inhibitor (either selpercatinib or pralsetinib), preferably in a clinical trial, if available.
Please note: This article is current as of January 12, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
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