Indications of Larotrectinib

Larotrectinib is indicated for the treatment of adult and pediatric patients with solid tumors that:

1.have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired  resistance mutation, 

2.are metastatic or where surgical resection is likely to result in severe morbidity, and

3.have no satisfactory alternative treatments or that have progressed following treatment.  Select patients for therapy based on an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and  duration of response. Continued approval for this indication may be  contingent upon verification and description of clinical benefit in confirmatory trials.

from FDA，2022.11