Retevmo™ (selpercatinib) capsules

40 mg, 80 mg

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RETEVMO™ (selpercatinib): FDA Approval and Indication

Selpercatinib is FDA-approved for the treatment of adult patients with metastatic RET fusion-positive NSCLC and patients 12 years and older with advanced or metastatic RET-mutant MTC or RET fusion-positive thyroid cancer who require systemic therapy.

Detailed Information

RETEVMO™ (selpercatinib) is a kinase inhibitor that is FDA-approved for the treatment of

  • adult patients with metastatic RET fusion-positive NSCLC

  • adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant MTC who require systemic therapy, and

  • adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).1

This indication is approved under accelerated approval based on ORR and DOR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).1

Enclosed Prescribing Information

RETEVMO™ (selpercatinib) capsules, for oral use, Lilly

Enclosed Patient Information

RETEVMO™ (selpercatinib) patient information, Lilly

References

1. Retevmo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

Glossary

DOR = duration of response

FDA = Food and Drug Administration 

MTC = medullary thyroid cancer

NSCLC = non-small cell lung cancer

ORR = overall response rate

RET = rearranged during transfection

Date of Last Review: April 30, 2020

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