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Retevmo ® (selpercatinib) capsules
40 mg, 80 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What are the approved indications for Retevmo® (selpercatinib)?
Selpercatinib is approved in adults with locally advanced or metastatic RET fusion-positive NSCLC or solid tumors and patients ≥12 years with advanced or metastatic RET-mutant MTC or RET fusion-positive thyroid cancer requiring systemic therapy.
Retevmo® (selpercatinib) Approved Indications
Retevmo® (selpercatinib) is a kinase inhibitor approved by the Food and Drug Administration (FDA) 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), and
- 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.1
The indications for MTC, thyroid cancer, and solid tumors are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trial(s).1
Enclosed Prescribing Information
Enclosed Patient Information
1Retevmo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
Date of Last Review: September 15, 2022