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. Author manuscript; available in PMC: 2024 Mar 19.
Published in final edited form as: Am J Manag Care. 2022 Jan;28(2 Suppl):S15–S25. doi: 10.37765/ajmc.2022.88834

TABLE 3.

Larotrectinib and Entrectinib Label Overview28,29,a

Attributes Larotrectinib Entrectinib
Indication Adults and children Adults and children 12 years and older
Dosing 100 mg twice a day for adults; 100 mg/m2 twice a day (to a maximum of 100 mg per dose) for children 600 mg once a day for adults; 300 mg/m2 once a day for children
Formulation Capsules and liquid Capsules
Response rate
 ORR 75% 57%
 CR 22% 7.4%
 PR 53% 50%
All-grade AEs in ≥ 20% of patients for either drug
 Fatigue 37% 48%
 Dizziness 28% 38%
 Nausea 29% 34%
 Dyspnea 18% 30%
 Myalgia 14% 28%
 Increased weight 15% 25%
 Arthralgia 14% 21%
 Vision disorders NR 21%
 Cough 26% 24%
 Vomiting 26% 24%
 Constipation 23% 46%
 Diarrhea 22% 35%
 Dysgeusia NR 44%
 Edema 15% 40%
 Dysesthesia NR 34%
 Cognitive impairment NR 27%
 Pyrexia 18% 21%
Warnings Hepatotoxicity, embryo-fetal toxicity, neurotoxicity Hepatotoxicity, embryo-fetal toxicity, CNS effects, congestive heart failure, skeletal fractures, hyperuricemia, QT interval prolongation, vision disorders
AE-related fatalities None Dyspnea (0.6%), pneumonia (0.6%), sepsis (0.6%), completed suicide (0.3%), large intestine perforation (0.3%), tumor lysis syndrome (0.3%)

AE, adverse event; CNS, central nervous system; CR, complete response; NR, not reported; ORR, objective response rate; PR, partial response.

a

For illustrative purposes only; cross-trial comparisons must not be made.