Larotrectinib Explained

Tradename:Vitrakvi
Dailymedid:Larotrectinib
Pregnancy Au:D
Routes Of Administration:By mouth, oropharyngeal
Atc Prefix:L01
Atc Suffix:EX12
Legal Au:S4
Legal Ca:Rx-only
Legal Ca Comment:[1] [2]
Legal Uk:POM
Legal Uk Comment:[3]
Legal Us:Rx-only
Legal Eu:Rx-only
Index2 Label:as salt
Cas Number:1223403-58-4
Pubchem:46188928
Drugbank:DB14723
Chemspiderid:44210503
Unii:PF9462I9HX
Kegg:D11137
Kegg2:D11138
Chembl:3889654
Stdinchi:1S/C21H22F2N6O2/c22-13-3-4-16(23)15(10-13)18-2-1-7-28(18)19-6-9-29-20(26-19)17(11-24-29)25-21(31)27-8-5-14(30)12-27/h3-4,6,9-11,14,18,30H,1-2,5,7-8,12H2,(H,25,31)/t14-,18+/m0/s1
Stdinchikey:NYNZQNWKBKUAII-KBXCAEBGSA-N
Synonyms:LOXO-101, ARRY-470
C:21
H:22
F:2
N:6
O:2
Smiles:O[C@H]1CCN(C1)C(=O)Nc2cnn3ccc(nc23)N4CCC[C@@H]4c5cc(F)ccc5F
Iupac Name:(3S)-N--3-hydroxypyrrolidine-1-carboxamide

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.

Research

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

External links

Notes and References

  1. Web site: Vitrakvi Product information . Health Canada . 25 April 2012 . 29 May 2022 . 30 May 2022 . https://web.archive.org/web/20220530062752/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=98037 . live .
  2. Web site: Summary Basis of Decision (SBD) for Vitrakvi . . 23 October 2014 . 29 May 2022 . 31 May 2022 . https://web.archive.org/web/20220531053203/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00455&lang=en . live .
  3. Web site: Vitrakvi 25mg hard capsules - Summary of Product Characteristics (SmPC) . (emc) . 7 March 2022 . 28 November 2022 . 28 November 2022 . https://web.archive.org/web/20221128235056/https://www.medicines.org.uk/emc/product/12100/smpc . live .
  4. Web site: Vitrakvi . Therapeutic Goods Administration (TGA) . 16 September 2020 . 22 September 2020 . 19 September 2020 . https://web.archive.org/web/20200919000203/https://www.tga.gov.au/apm-summary/vitrakvi . live .
  5. Web site: Vitrakvi- larotrectinib capsule Vitrakvi- larotrectinib solution, concentrate . DailyMed . 26 July 2019 . 22 September 2020 . 7 April 2021 . https://web.archive.org/web/20210407220342/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c8ca614-58b2-4aa4-83d3-0387a8f782fd . live .
  6. Web site: Larotrectinib. Statement on a Nonproprietary Name Adopted by the USAN Council. 26 October 2016. American Medical Association (AMA). 31 January 2017. 13 March 2018. https://web.archive.org/web/20180313031528/https://searchusan.ama-assn.org/usan/documentDownload?uri=%2Funstructured%2Fbinary%2Fusan%2Flarotrectnib.pdf. live.
  7. Book: Berger S, Martens UM, Bochum S . Larotrectinib (LOXO-101) . Small Molecules in Oncology. Recent Results in Cancer Research Fortschritte der Krebsforschung. Progres dans les Recherches Sur le Cancer. 211 . 141–151 . 2018 . 30069765 . 10.1007/978-3-319-91442-8_10 . 978-3-319-91441-1 .
  8. Federman N, McDermott R . Larotrectinib, a highly selective tropomyosin receptor kinase (TRK) inhibitor for the treatment of TRK fusion cancer . Expert Review of Clinical Pharmacology . 12 . 10 . 931–939 . October 2019 . 31469968 . 10.1080/17512433.2019.1661775 . free .
  9. Scott LJ . Larotrectinib: First Global Approval . Drugs . 79 . 2 . 201–206 . February 2019 . 30635837 . 10.1007/s40265-018-1044-x . 57772716 .
  10. Web site: Larotrectinib. AdisInsight. 31 January 2017. 12 March 2018. https://web.archive.org/web/20180312022533/http://adisinsight.springer.com/drugs/800040495. live.
  11. Web site: Novel Agent Shows Antitumor Activity in TRK-Fusion Cancers. June 2017 . 9 June 2017 . 24 January 2021 . https://web.archive.org/web/20210124004620/https://www.medpagetoday.com/meetingcoverage/asco/65775 . live .
  12. Web site: FDA approves larotrectinib for solid tumors with NTRK gene fusions. 26 November 2018. U.S. Food and Drug Administration (FDA). 22 September 2020. 24 March 2021. https://web.archive.org/web/20210324103932/https://www.fda.gov/drugs/fda-approves-larotrectinib-solid-tumors-ntrk-gene-fusions. live.
  13. News: Dun L. 27 November 2018. FDA approves a new cancer drug targeted to genetic mutation, not cancer type. NBC. 3 December 2018. 2 December 2018. https://web.archive.org/web/20181202181020/https://www.nbcnews.com/health/health-news/fda-approves-new-cancer-drug-targeted-genetic-mutation-not-cancer-n940656. live.
  14. New Drug Therapy Approvals 2018 . U.S. Food and Drug Administration (FDA) . January 2019 . PDF . 16 September 2020 . 17 September 2020 . https://web.archive.org/web/20200917055627/https://www.fda.gov/media/120357/download . live .
  15. News: 'Revolutionary' new class of cancer drugs approved. Gallagher J. 23 September 2019. 30 September 2019. en-GB. 26 September 2019. https://web.archive.org/web/20190926003723/https://www.bbc.com/news/health-49798628. live.
  16. Web site: Vitrakvi EPAR . European Medicines Agency (EMA) . 23 July 2019 . 22 September 2020 . 2 October 2020 . https://web.archive.org/web/20201002004734/https://www.ema.europa.eu/en/medicines/human/EPAR/vitrakvi . live .

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