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Augtyro

REPOTRECTINIB

Manufacturer: E.R. Squibb & Sons, L.L.C.

Score: 141.0

Quick Summary

Augtyro (repotrectinib) is a kinase inhibitor used for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) and adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The recommended dosage is 160 mg orally once daily for 14 days, then increased to 160 mg twice daily. Important safety information includes warnings for central nervous system effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, and hyperuricemia. There are no contraindications listed. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
  • Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion

Important Safety Information

Warning

Central nervous system effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, and hyperuricemia

Contraindications

Adverse Reactions

  • Dizziness
  • Dysgeusia
  • Peripheral neuropathy
  • Constipation
  • Dyspnea
  • Fatigue
  • Ataxia
  • Cognitive impairment
  • Muscular weakness
  • Nausea

Dosing Recommendations

General Guidance

Dosage reductions and interruptions may be necessary for adverse reactions

ROS1-positive NSCLC or NTRK gene fusion-positive solid tumors

Adult Dose

160 mg orally once daily for 14 days, then increased to 160 mg twice daily

Pediatric Dose

Same as adult dose for pediatric patients 12 years of age and older

Special Population Considerations

Pregnancy

  • Augtyro can cause fetal harm when administered to a pregnant woman
  • Advise pregnant women of the potential risk to a fetus

Nursing Mothers

Pediatric Use

  • The safety and effectiveness of Augtyro have been established in pediatric patients 12 years of age or older with NTRK gene fusion-positive solid tumors
  • Use of Augtyro in pediatric patients younger than 12 years of age is not established

Geriatric Use

  • No clinically meaningful differences in safety and efficacy were observed between patients younger than 65 years of age and patients 65 years of age or older

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