FDA accelerates approval of Vitrakvi (larotrectinib) for treatment of late-stage or metastatic solid tumors

protomyglobulin receptor kinase (TRK) fusion tumors, the NTRK gene merges with unrelated genes, leading to the production of mutated TRK proteinstoday, Loxo Oncology and Bayer(http://jointly announced thatFDA(http://to accelerate the approval of the joint development of Vitrakvi (larotrectinib) for the treatment of adults and children with NTRK gene fusion of late-stage or metastatic solid tumors, regardless of the region where cancer occursabout LarotrectinibLarotrectinib is a new generation of highly specific oral TRK inhibitors developed by Loxo Oncology and BayerLarotrectinib is a new drug(http://of a new drug(http:// that has targeted specific gene mutations from early development, not cancer
speciesLarotrectinib has been identified by the FDA as a ground-breaking treatment, orphan drug qualification and a rare pediatric diseaseIn addition, the experimental design of the "basket trial" was used in the clinicaltrial(http://) to test the efficacy of the drug during thedevelopment of theDrug(http://That is, not according to the cancerous tissue to raise patients, but according to the molecular characteristics of the tumor to raise patientsthe studythis approval is based on larotrectinib's performance in a number of clinical trialsAccording to the latest data released at the annual meeting of the European Society for Oncology (ESMO) in October, larotrectinib was able to achieve an objective remission rate (ORR) of 80 percent of the 55 patients with TRK fusion cancer that could be measured by the RECIST standardnotably, larotrectinib has performed consistently across a variety of cancer types