Bayer‘s Vitrakvi is a kinase inhibitor that is FDA indicated to treat adult and pediatric patients with solid tumors. Specifically, FDA indicates it for solid tumors with the following criteria:
- Presence of a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation.
- Metastatic or where surgical resection is likely to result in severe morbidity.
- Without satisfactory alternative treatments or that have progressed following treatment.
FDA approved the drug for this indication under its accelerated approval program. The agency notes that continued approval for this indication may require further data from confirmatory trials.
Filed Under: Oncology