By Fineline Cube 
Germany-based Bayer (ETR: BAYN) announced that it has received full approval from the US Food and Drug Administration (FDA) for its tropomyosin receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib). The drug is now approved for adult and pediatric patients with solid tumors harboring an NTRK gene fusion without a known acquired resistance mutation, which are metastatic or where surgical resection is likely to result in severe morbidity, and for whom there are no satisfactory alternative treatments or that have progressed following treatment.
Clinical Trial Results
The approval is based on comprehensive results from three multi-center, open-label, single-arm clinical studies: LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431). These studies included 339 pediatric and adult patients with unresectable or metastatic solid tumors with an NTRK gene fusion. Key findings include:
- Overall Response Rate (ORR): 60% (95% CI: 55%-65%)
- Complete Response (CR) Rate: 24%
- Partial Response (PR) Rate: 36%
- Median Duration of Response (DOR): 43.3 months
Drug Mechanism
Vitrakvi is a TRK inhibitor designed to target tumors with NTRK gene fusions. By inhibiting the TRK signaling pathway, the drug effectively disrupts the growth and survival of cancer cells. This mechanism of action makes Vitrakvi a targeted therapy for a broad range of solid tumors driven by NTRK alterations.-Fineline Info & Tech