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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.
Does Retevmo® (selpercatinib) have a companion diagnostic?
Selpercatinib has an FDA-approved companion diagnostic test for RET gene fusion (NSCLC, thyroid cancer, or other solid tumors) or specific RET gene mutation (MTC) in tumor specimens.
Selpercatinib Patient Selection
Select patients for treatment with selpercatinib based on the presence of a rearranged during transfection (RET) gene fusion (non-small cell lung cancer [NSCLC], thyroid cancer, or other solid tumors) or specific RET gene mutation (medullary thyroid cancer [MTC]) in tumor specimens. Information on Food and Drug Administration (FDA)-approved test(s) for the detection of RET gene fusions and RET gene mutations is available at: http://www.fda.gov/CompanionDiagnostics.1
An FDA-approved companion diagnostic test for the detection of RET gene fusions and RET gene mutations in plasma or in tumors other than NSCLC and thyroid cancer is not currently available.1
Retevmo® (selpercatinib) Approved Indications
Selpercatinib) is a kinase inhibitor approved by the FDA for the treatment of
- adult patients with locally advanced or metastatic NSCLC with a RET gene fusion, as detected by an FDA-approved test
- adult and pediatric patients 12 years of age and older with advanced or 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
Companion Diagnostic Overview
A companion diagnostic is a medical device that
- provides essential information for the safe and effective use of a corresponding drug or biological product
- can identify patients that are most likely to receive benefit or patients with increased risk of serious drug-related side effects, and
- can be used to monitor patient response so that treatment may be adjusted to attain improved safety or effectiveness.2
Enclosed Prescribing Information
1Retevmo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
2Companion Diagnostics. Food and Drug Administration. Published December 7, 2018. Accessed September 16, 2022. https://www.fda.gov/medical-devices/vitro-diagnostics/companion-diagnostics
Date of Last Review: September 21, 2022