NEW YORK – The US Food and Drug Administration on Thursday granted full approval to Bayer's TRK inhibitor Vitrakvi (larotrectinib) for treating adult and pediatric patients with previously treated metastatic NTRK fusion-positive solid tumors without a known acquired resistance mutation.
The full approval makes the treatment available to essentially the same population as when the agency granted accelerated approval to Vitrakvi in 2018, which included patients whose tumors are metastatic or where surgical resection is likely to result in severe morbidity and who have no satisfactory alternative treatments or who have progressed following treatment.
The agency granted full approval based on pooled results from three single-arm clinical trials: LOXO-TRK-14001, SCOUT, and NAVIGATE. These pooled results showed an overall response rate of 60 percent and complete response rate of 24 percent across NTRK fusion-positive pediatric and adult solid tumor patients. The median duration of response in these studies was 43.3 months.
Vitrakvi has two approved companion diagnostics, Foundation Medicine's FoundationOne CDx comprehensive genomic profiling test and Illumina's TruSight Oncology comprehensive assay, to identify patients with NTRK gene fusions.
Bristol Myers Squibb's Augtyro (repotrectinib) and Genentech's Rozlytrek (entrectinib) also have accelerated approval in the tumor-agnostic setting for NTRK fusion-positive patients in the US. Vitrakvi is the first TRK inhibitor to receive full FDA approval.