Across solid tumors
Study design: Pooled efficacy analysis based on 3 open-label, single-arm clinical studies in adult and pediatric patients with unresectable or metastatic solid tumors with an NTRK gene fusion.1
VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and 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.
*TRK, tropomyosin receptor kinase.
aCR, complete response; mDOR, median duration of response; NE, not evaluable; NTRK, neurotrophic receptor tyrosine kinase; ORR, overall response rate; PR, partial response.
c5% were pathological complete response. Patients undergoing a surgical resection whose post-operative pathologic assessment showed no viable tumor cells and negative margins were pathological complete responders provided that no other sites of disease were present.1
dBased on medical claims and prescription data claims for the period August 2019 through December 2020. Validated by IQVIA in March 2021.
+ denotes ongoing response.