FDA Accepts New Drug Application for Larotrectinib in Treatment of Certain Solid Tumors
Posted: Wednesday, May 30, 2018
On May 29, 2018, the U.S. Food and Drug Administration (FDA) accepted Loxo Oncology’s New Drug Application and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Larotrectinib is an oral and highly selective investigational tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment of patients with cancers that harbor an NTRK gene fusion. Growing research suggests NTRK genes, which encode for TRKs, may become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.
In clinical trials, larotrectinib demonstrated antitumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type. In an analysis of 55 Response Evaluation Criteria in Solid Tumors–evaluable adult and pediatric patients with NTRK gene fusions, larotrectinib yielded a 75% centrally assessed confirmed overall response rate and an 80% investigator-assessed confirmed overall response rate across multiple types of solid tumors. The majority of all adverse events reported were grade 1 or 2.
