RETEVMO

SELPERCATINIB

Manufacturer: Eli Lilly and Company

Score: 141.0

Quick Summary

RETEVMO (selpercatinib) is a kinase inhibitor used 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, and for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, or with advanced or metastatic thyroid cancer with a RET gene fusion. The recommended dosage is based on weight for adult and adolescent patients, and on body surface area for pediatric patients. Important safety information includes warnings for hepatotoxicity, interstitial lung disease/pneumonitis, hypertension, QT interval prolongation, hemorrhagic events, and hypersensitivity reactions.

Key Clinical Findings and Indications

Treatment of adult patients with locally advanced or metastatic NSCLC with a RET gene fusion
Treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic MTC with a RET mutation
Treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion

Important Safety Information

Warning

Hepatotoxicity, interstitial lung disease/pneumonitis, hypertension, QT interval prolongation, hemorrhagic events, and hypersensitivity reactions

Contraindications

Adverse Reactions

Edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, headache
Musculoskeletal pain, diarrhea, headache, nausea, vomiting, coronavirus infection, abdominal pain, fatigue, pyrexia, hemorrhage

Dosing Recommendations

General Guidance

Reduce dose in patients with severe hepatic impairment, and for concomitant use of strong and moderate CYP3A inhibitors

Adult and adolescent patients 12 years of age or older

Adult Dose

Less than 50 kg: 120 mg orally twice daily, 50 kg or greater: 160 mg orally twice daily

Pediatric Dose

2 to less than 12 years of age: based on body surface area

Special Population Considerations

Pregnancy

Based on findings from animal studies, and its mechanism of action, RETEVMO can cause fetal harm when administered to a pregnant woman

Nursing Mothers

Pediatric Use

The safety and effectiveness of RETEVMO have been established in pediatric patients 2 years of age and older for the treatment of advanced or metastatic MTC with a RET mutation, or with advanced or metastatic thyroid cancer with a RET gene fusion
Monitor growth plates in pediatric patients with open growth plates

Geriatric Use

Of 796 patients who received RETEVMO, 34% (268 patients) were ≥65 years of age and 9% (74 patients) were ≥75 years of age
No overall differences were observed in the safety or effectiveness of RETEVMO between patients who were ≥65 years of age and younger patients

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