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Larotrectinib

Larotrectinib, sold under the brand name Vitrakvi, is a medication for the treatment of cancer.[4][5][6] It is an inhibitor of tropomyosin kinase receptors TrkA, TrkB, and TrkC.[7][8][9] It was discovered by Array BioPharma and licensed to Loxo Oncology in 2013.

Larotrectinib was initially awarded orphan drug status in 2015, for soft tissue sarcoma, and breakthrough therapy designation in 2016 for the treatment of metastatic solid tumors with NTRK fusion.[10] Some clinical trial results were announced in 2017.[11] On 26 November 2018, Larotrectinib was approved by the FDA.[12]

Larotrectinib was the first drug to be specifically developed and approved to treat any cancer containing certain mutations, as opposed to cancers of specific tissues (i.e., the approval is "tissue agnostic"). Several earlier drugs, including pembrolizumab, were eventually approved by the FDA for treatment of specific mutations independent of the type of cancer, but those drugs had been initially developed for specific cancer types.[13] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[14]

Larotrectinib was approved for medical use in the European Union in September 2019.[15][16] It was approved for medical use in Australia in August 2020.[4]

Research

Phase II clinical trials evaluating the drug for efficacy and safety in treating several types of solid tumors are ongoing.[17]

External links

References

  1. Vitrakvi Product information Health Canada, 25 April 2012, retrieved 29 May 2022^
  2. Summary Basis of Decision (SBD) for Vitrakvi Health Canada, 23 October 2014, retrieved 29 May 2022^
  3. Vitrakvi 25mg hard capsules - Summary of Product Characteristics (SmPC) (emc), 7 March 2022, retrieved 28 November 2022^
  4. Vitrakvi Therapeutic Goods Administration (TGA), 16 September 2020, retrieved 22 September 2020^
  5. Vitrakvi- larotrectinib capsule Vitrakvi- larotrectinib solution, concentrate DailyMed, 26 July 2019, retrieved 22 September 2020^
  6. Larotrectinib Statement on a Nonproprietary Name Adopted by the USAN Council, American Medical Association (AMA), 26 October 2016, retrieved 31 January 2017^
  7. Small Molecules in Oncology 2018^
  8. Larotrectinib, a highly selective tropomyosin receptor kinase (TRK) inhibitor for the treatment of TRK fusion cancer Expert Review of Clinical Pharmacology, October 2019^
  9. Larotrectinib: First Global Approval Drugs, February 2019^
  10. Larotrectinib AdisInsight, retrieved 31 January 2017^
  11. Novel Agent Shows Antitumor Activity in TRK-Fusion Cancers. June 2017 retrieved 9 June 2017^
  12. FDA approves larotrectinib for solid tumors with NTRK gene fusions U.S. Food and Drug Administration (FDA), 26 November 2018, retrieved 22 September 2020^
  13. FDA approves a new cancer drug targeted to genetic mutation, not cancer type NBC, 27 November 2018, retrieved 3 December 2018^
  14. New Drug Therapy Approvals 2018 U.S. Food and Drug Administration (FDA), January 2019, retrieved 16 September 2020^
  15. 'Revolutionary' new class of cancer drugs approved 23 September 2019, retrieved 30 September 2019^
  16. Vitrakvi EPAR European Medicines Agency (EMA), 23 July 2019, retrieved 22 September 2020^
  17. {{ClinicalTrialsGov|NCT02576431|A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumors}}^