FDA approved Retevmo (selpercatinib) for RET Fusion-Positive Solid TumorsFDA approved Retevmo for more cancers with RET gene fusions

FDA From the archive Source published April 10, 2024 Summary added July 18, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider Retevmo for RET fusion-positive solid tumors after prior systemic therapy or when no alternatives exist.

The FDA has approved Retevmo (selpercatinib) for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors harboring a RET gene fusion, as detected by an FDA-approved test, who have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Retevmo is a kinase inhibitor that targets RET fusions and mutations. The approval expands the use of Retevmo, which was previously approved for RET fusion-positive non-small cell lung cancer and RET-altered thyroid cancers. Clinicians should select patients based on the presence of a RET gene fusion in tumor specimens using an FDA-approved test. The recommended dosing varies by age, weight, and body surface area.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Selpercatinib is a kinase inhibitor that inhibits wild-type RET and multiple RET fusions and mutations. It also inhibits VEGFR1 and VEGFR2 at clinically achievable concentrations.

Indication & Patient Population

Retevmo is indicated for adult and pediatric patients 2 years and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response.

Dosing & Administration

For adult and adolescent patients 12 years or older: less than 50 kg, 120 mg orally twice daily; 50 kg or greater, 160 mg twice daily. For pediatric patients 2 to less than 12 years: based on body surface area (BSA). For BSA 0.33 to 0.65 m², 40 mg three times daily; 0.66 to 1.08 m², 80 mg twice daily; 1.09 to 1.52 m², 120 mg twice daily; ≥1.53 m², 160 mg twice daily. Retevmo may be taken with or without food unless coadministered with a PPI. For patients unable to swallow, only 40 mg tablets may be dispersed in water and administered orally or via feeding tube. Reduce dose in severe hepatic impairment.

Key Clinical Trial Data

Trial data not available in label for this indication. The label references Clinical Studies (14.4) for efficacy data supporting accelerated approval.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Retevmo is a targeted therapy for RET fusion-positive solid tumors after progression on prior systemic therapy or when no satisfactory alternatives exist. It is a second-line or later option for patients with RET fusions.

The FDA has approved Retevmo (selpercatinib) for a new group of patients. This drug is now available for adults and children ages 2 and older with advanced solid tumors that have a specific genetic change called a RET gene fusion. These patients must have tried other treatments that no longer work, or have no good treatment options left. Retevmo is a type of targeted therapy called a kinase inhibitor. It works by blocking signals that help cancer cells grow.

This approval is based on how well the drug shrinks tumors and how long that effect lasts. It is an accelerated approval, which means the FDA is allowing earlier access while more studies confirm the benefit. Retevmo was already approved for certain lung and thyroid cancers with RET changes. Now it can be used for other solid tumors with RET fusions, no matter where in the body the cancer started.

Doctors will use an FDA-approved test to find RET gene fusions in tumor samples. The dose of Retevmo depends on a person's age, weight, and body surface area. This is not a cure, but it offers a new option for people with few choices.

If you or a loved one has a solid tumor that has not responded to treatment, talk to your doctor about whether testing for RET fusions could help. This approval does not mean the drug is right for everyone. Your doctor can help you understand the risks and benefits.

What this means for you:

Retevmo is now approved for more cancers with RET fusions, but talk to your doctor about testing and treatment options.

Study Details

Study typeFda approval

PublishedApr 2024

View Original Abstract ↓

1 INDICATIONS AND USAGE RETEVMO ® is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test ( 1.1 ) Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy ( 1.2 ) Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) ( 1.3 ) Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options 1 ( 1.4 ) 1 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). 1.1 RET Fusion-Positive Non-Small Cell Lung Cancer RETEVMO ® is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. 1.2 RET -Mutant Medullary Thyroid Cancer RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. 1.3 RET Fusion-Positive Thyroid Cancer RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 1.4 Other RET Fusion-Positive Solid Tumors RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.4 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

FDA approved Retevmo (selpercatinib) for RET Fusion-Positive Solid TumorsFDA approved Retevmo for more cancers with RET gene fusions

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FDA approved Retevmo (selpercatinib) for RET Fusion-Positive Solid TumorsFDA approved Retevmo for more cancers with RET gene fusions

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