Vitrakvi Approval History
Reviewed by J.Stewart BPharm Last updated on Nov 26, 2018.
FDA Approved: Yes (First approved November 26, 2018)
Brand name: Vitrakvi
Generic name: larotrectinib
Dosage form: Capsules and Oral Solution
Company: Loxo Oncology, Inc.
Treatment for: TRK Fusion Cancers
Vitrakvi (larotrectinib) is an oral selective tropomyosin receptor kinase (TRK) inhibitor for the treatment solid tumors harboring NTRK-fusion proteins.
- Research suggests that the NTRK genes can become abnormally fused to other genes, producing a TRK fusion protein that can lead to the development of solid tumors across various sites of the body.
- 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 efficacy of larotrectinib was studied in three clinical trials that included 55 pediatric and adult patients with solid tumors that had an identified NTRK gene fusion. 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.
- Vitrakvi (larotrectinib) is taken orally twice daily.
- Common side effects (≥ 20%) 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 received an accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Vitrakvi’s clinical benefit.
Development History and FDA Approval Process for Vitrakvi
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