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Vitrakvi FDA Approval History

Last updated by Judith Stewart, BPharm 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 timeline for Vitrakvi

Nov 26, 2018Approval FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers
Oct 21, 2018Larotrectinib Delivers 81% Overall Response Rate in an Expanded Dataset of 109 TRK Fusion Cancer Patients Across Ages and Tumor Types
May 29, 2018FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
Mar 26, 2018Loxo Oncology Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancer
Feb 21, 2018Loxo Oncology Announces Publication of Larotrectinib Clinical Data in The New England Journal of Medicine
Dec 20, 2017Loxo Oncology Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancers
Dec 12, 2017Loxo Oncology Announces Updated Larotrectinib Pediatric Clinical Trial Data Demonstrating Continued Durability of Response in TRK Fusion Cancers
Jun  3, 2017Loxo Oncology Breakthrough Therapy Larotrectinib Demonstrates 76 Percent Confirmed Objective Response Rate in TRK Fusion Adult and Pediatric Cancers as Presented at the American Society of Clinical Oncology

Further information

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