Bayer’s Vitrakvi Earns First Tumor-Agnostic Approval in EU

Bayer’s oncology drug Vitrakvi (larotrectinib) has earned the first tumor-agnostic approval in the EU for adults and children with a rare genomic alteration.

Vitrakvi, a drug specifically developed as a TRK fusion treatment, was approved for children and adults with locally advanced or metastatic solid tumors with NTRK gene fusion, a rare form of cancer that impacts patients across various tumor types.

The EMA’s green light was supported by study data from 102 patients across a phase 1 trial of adult patients, a phase 2 trial in adults and adolescents and a phase 1-2 pediatric trial.