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Retevmo ® (selpercatinib) tablets
40 mg, 80 mg, 120 mg, 160 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 the United States in adults with RET fusion-positive NSCLC and in patients 2 years of age and older with RET-mutant MTC, RET fusion-positive thyroid cancer and RET fusion-positive solid tumors.
Selpercatinib Approved Indications in the United States
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 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
- 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), and
- 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
*The indication for solid tumors is 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
Selpercatinib Approved Formulations in the United States
On April 10, 2024, the FDA approved a new tablet dosage form of selpercatinib.2 Selpercatinib tablets will be available in 40mg, 80mg, 120mg, and 160mg strengths in the second half of 2024.1
Selpercatinib capsules will be available until the tablet transition is complete. Once the transition is complete, capsules will no longer be available.
Enclosed Prescribing Information
References
1Retevmo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
2Drugs@FDA: FDA Approved Drug Products. Retevmo® (selpercatinib). New Drug Application number: 213246. Accessed April 10, 2024. http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213246
Date of Last Review: September 30, 2024