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Retevmo FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 2, 2022.

FDA Approved: Yes (First approved May 8, 2020)
Brand name: Retevmo
Generic name: selpercatinib
Dosage form: Capsules
Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors

Retevmo (selpercatinib) is a kinase inhibitor used for the treatment of certain cancers caused by abnormal RET genes.

  • 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.
    • Adult and pediatric patients 12 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.
    • Adult and pediatric patients 12 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).
    • Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Retevmo capsules are administered orally, twice daily.
  • Warnings and precautions associated with Retevmo include hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, hypertension, QT interval prolongation, hemorrhagic events, hypersensitivity reactions, tumor lysis syndrome, risk of impaired wound healing, hypothyroidism, and embryo-fetal toxicity.
  • Common adverse reactions include edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. Common laboratory abnormalities include decreased lymphocytes, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), decreased sodium, and decreased calcium.

Development timeline for Retevmo

DateArticle
Aug 22, 2023Retevmo Demonstrates Superior Progression-Free Survival Compared to Approved Multikinase Inhibitors in RET-Mutant Medullary Thyroid Cancer
Aug  4, 2023Retevmo Demonstrates Superior Progression-Free Survival for Adults with Newly-Diagnosed Non-Small Cell Lung Cancer
Sep 21, 2022Approval FDA Approves Lilly's Retevmo (selpercatinib), the First and Only RET Inhibitor for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type
May  8, 2020Approval FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers
Jan 29, 2020Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
Dec 30, 2019Lilly Opens Phase 3 Clinical Trial for Selpercatinib (LOXO-292) in RET-Mutant Medullary Thyroid Cancer
Sep 29, 2019Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers
Sep  9, 2019Lilly Announces Positive Results for Selpercatinib (LOXO-292), Demonstrating a 68 Percent Objective Response Rate and Sustained Durability in Heavily Pretreated RET Fusion-Positive Non-Small Cell Lung Cancer
Oct 15, 2018Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292 for the Treatment of RET Fusion-Positive Thyroid Cancer

See also

Retevmo (selpercatinib) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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