The FDA approved Vitrakvi (Loxo Oncology) in fast forward for the treatment of cancer in adults and children with a certain genetic mutation (biomarker). As noted by the FDA, this is a second drug approved for the treating of tumors regardless of their location.
Vitrakvi is intended for the treatment of adults and children with various neoplasms with mutations characterized by a fusion of the TRK gene and with the progressive disease after therapy. Such mutations are rare and located in many body parts.
The efficacy of the drug was studied in three clinical studies involving 55 patients with solid tumors and fusion of the TRK gene with metastases and those who didn’t have surgery, as well as patients with progressive disease after treatment.
According to the data obtained, the overall response rate was 75%. In 73% of patients, the response was maintained for at least six months, and in 39% – for one year or more. Among the tumors responded to the therapy are soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer, and lung cancer.
Side effects associated with taking Vitrakvi were: fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting, and increased levels of liver enzymes.