FDA Okays Loxo Oncology - Bayer Cancer Drug

(RTTNews) - The U.S. Food and Drug Administration said it granted accelerated approval to Vitrakvi or larotrectinib, a treatment for adult and pediatric patients whose cancers have a specific genetic feature, biomarker. The FDA granted the approval of Vitrakvi to Loxo Oncology (LOXO).

Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase or NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed following treatment.

Larotrectinib demonstrated a 75 percent overall response rate across different types of solid tumors. These responses were durable, with 73 percent of responses lasting at least six months, and 39 percent lasting a year or more at the time results were analyzed. Examples of tumor types with an NTRK fusion that responded to larotrectinib include soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer and lung cancer.

The FDA said that Common side effects reported by patients receiving Vitrakvi in clinical trials include fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting, and increased AST and ALT enzyme blood levels in the liver.

Vitrakvi, developed by Bayer and Loxo Oncology, Inc., is a CNS active TRK inhibitor designed to inhibit these proteins. Vitrakvi will be available in oral capsules as well as a liquid formulation for adults and children, Loxo Oncology said.