Shots: The NDA submission is based on P-I study of adult patients, the P-II NAVIGATE trial in adult and adolescent patients and the P- I/II pediatric SCOUT trial. These trials […]readmore
Tags : larotrectinib
Shots: The US FDA approved FoundationOneCDx to be used as a CDx for Vitrakvi (larotrectinib) to identify patients with NTRK fusions across all solid tumors. The genomic test is currently […]readmore
Shots: The MAA is submission is based on P-I trial of adult patients, P-II NAVIGATE study in adult and adolescent patients and the P-I/II pediatric SCOUT study. These trials evaluate […]readmore
Shots: The approval is based on the pooled clinical study including P-I study in adults, P-II NAVIGATE study in adults & adolescents & P-I/II pediatric SCOUT study assessing Vitrakvi in […]readmore
Shots: Vitrakvi has received approval under Health Canada’s NOC/c policy based on the clinical study evaluating Vitrakvi in adults and children with solid tumors harboring NTRK fusion The clinical study […]readmore
Shots: With the acquisition of Loxo by Eli Lilly, Bayer exercises its option and get exclusive WW rights to develop and commercialize Vitrakvi and BAY 2731954 including in the US. […]readmore
Shots: The approval is based on combined data from P-I adult trial, P-II NAVIGATE trial and P-I/II pediatric SCOUT trial assessing Vitrakvi in solid tumors with neurotrophic receptor tyrosine kinase […]readmore