FDA approved Retevmo (selpercatinib) for RET-Driven CancersFDA approved new drug Retevmo for certain lung and thyroid cancers.

FDA From the archive Source published May 8, 2020 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 patients with RET fusion-positive NSCLC, RET-mutant MTC, or RET fusion-positive thyroid or solid tumors.

The FDA has approved Retevmo (selpercatinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, as detected by an FDA-approved test. Additionally, the drug is approved for adult and pediatric patients 2 years and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, advanced or metastatic RET fusion-positive thyroid cancer that is radioactive iodine-refractory, and locally advanced or metastatic RET fusion-positive solid tumors that have progressed on prior systemic treatment or have no satisfactory alternatives. The approval for solid tumors is under accelerated approval based on overall response rate and duration of response. Retevmo is a kinase inhibitor that targets RET fusions and mutations, offering a targeted therapy option for these genetically defined cancers.

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

Mechanism of Action

Retevmo is a kinase inhibitor that inhibits wild-type RET and multiple RET fusions and mutations. It also inhibits VEGFR1, VEGFR2, and VEGFR3 at clinically relevant concentrations.

Indication & Patient Population

Retevmo is indicated for: - Adult patients with locally advanced or metastatic NSCLC with a RET gene fusion. - Adult and pediatric patients 2 years and older with advanced or metastatic MTC with a RET mutation who require systemic therapy. - Adult and pediatric patients 2 years and older with advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and are radioactive iodine-refractory. - Adult and pediatric patients 2 years and older with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or after prior systemic treatment or have no satisfactory alternative options (accelerated approval).

Dosing & Administration

Select patients based on presence of RET gene fusion or mutation using an FDA-approved test. For adults and adolescents 12 years and 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: dosing based on body surface area (see label). Administer until disease progression or unacceptable toxicity. May take with or without food unless coadministered with a PPI. For patients unable to swallow, disperse 40 mg tablets only. Reduce dose in severe hepatic impairment.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Retevmo provides a targeted therapy option for patients with RET-driven cancers, including NSCLC, MTC, and other solid tumors. It is indicated for use after prior systemic therapy or when no satisfactory alternatives exist, with accelerated approval for solid tumors.

The FDA has approved a new drug called Retevmo (selpercatinib) for patients with certain cancers that have a specific genetic change. Retevmo is a targeted therapy that works by blocking a protein called RET, which helps some cancers grow. It is approved for adults with non-small cell lung cancer that has a RET gene fusion and has spread or cannot be removed by surgery. It is also approved for adults and children age 2 and older with advanced medullary thyroid cancer that has a RET mutation, and for certain patients with RET fusion-positive thyroid cancer or other solid tumors that have not responded to other treatments.

This approval is based on studies showing that Retevmo can shrink tumors in many patients. For the solid tumor approval, it is an accelerated approval, meaning more studies are needed to confirm the benefit. Retevmo is taken as a capsule by mouth, and common side effects include dry mouth, diarrhea, and high blood pressure.

If you or a loved one has one of these cancers, this new option may be worth discussing with your doctor. However, Retevmo is only for patients whose tumors have a specific RET gene change, which can be found with an FDA-approved test. Not everyone with these cancers will benefit from this drug. Talk to your healthcare team to see if testing and treatment with Retevmo is right for you.

What this means for you:

Retevmo is a new targeted drug for certain lung and thyroid cancers with a RET gene change.

Study Details

Study typeFda approval

PublishedMay 2020

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-Driven CancersFDA approved new drug Retevmo for certain lung and thyroid cancers.

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FDA approved Retevmo (selpercatinib) for RET-Driven CancersFDA approved new drug Retevmo for certain lung and thyroid cancers.

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