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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.
Is there an expanded access or compassionate use program available for Retevmo® (selpercatinib)?
Since selpercatinib is now commercially available in the United States, enrollment in the expanded access program has closed.
Expanded Access / Compassion Use Program for Retevmo® (selpercatinib)
Expanded access is a mechanism for acquiring treatment with an investigational drug until that drug is commercially available for any indication.1 Since selpercatinib is now approved by the Food and Drug Administration (FDA) in the United States, enrollment in the expanded access program has closed.
Eli Lilly and company encourages patients to participate in clinical trials whenever possible. Patient participation in clinical trials allows patients to contribute to our understanding of a compound while helping Lilly to obtain the data necessary to advance the clinical development of the compound. Patients and their physicians can review ongoing and planned studies by visiting www.clinicaltrials.gov.1
Selpercatinib Approved Indications
Retevmo® (selpercatinib) is a kinase inhibitor approved by the 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.2
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).2
Enclosed Prescribing Information
1Eli Lilly and Company. Expanded Access. Accessed September 15, 2022. https://www.lilly.com/discovery/clinical-trials/expanded-access.
2Retevmo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
Date of Last Review: September 15, 2022