Larotrectinib, sold under the brand name Vitrakvi, is a medication for the treatment of cancer. It is an inhibitor of tropomyosin kinase receptors

TrkA Tropomyosin receptor kinase A (TrkA), also known as high affinity nerve growth factor receptor, neurotrophic tyrosine kinase receptor type 1, or TRK1-transforming tyrosine kinase protein is a protein that in humans is encoded by the ''NTRK1'' gen ...

TrkB Tropomyosin receptor kinase B (TrkB), also known as tyrosine receptor kinase B, or BDNF/NT-3 growth factors receptor or neurotrophic tyrosine kinase, receptor, type 2 is a protein that in humans is encoded by the ''NTRK2'' gene. TrkB is a recept ...

, and

TrkC Tropomyosin receptor kinase C (TrkC), also known as NT-3 growth factor receptor, neurotrophic tyrosine kinase receptor type 3, or TrkC tyrosine kinase is a protein that in humans is encoded by the ''NTRK3'' gene. TrkC is the high affinity cata ...

. It was discovered by Array BioPharma and licensed to

Loxo Oncology Loxo may refer to: * Loxo (nymph), one of the nymphs of archery in Greek mythology * Loxo, a character in the 1934 novel ''Speedy in Oz'' * Loxo (Dungeons & Dragons), a fictional monster in roleplaying games * ''Loxo'' (bivalve), an extinct genus ...

in 2013. Larotrectinib was initially awarded

orphan drug status An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the condition ...

in 2015, for soft tissue sarcoma, and

breakthrough therapy Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "b ...

designation in 2016 for the treatment of metastatic solid tumors with NTRK fusion. Some clinical trial results were announced in 2017. On 26 November 2018, Larotrectinib was approved by the FDA. 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 Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody, more specifically a PD-1 inhibitor, used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cerv ...

, 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. The U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) considers it to be a

first-in-class medication A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medic ...

. Larotrectinib was approved for medical use in the European Union in September 2019. 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.

References

External links

* * Tissue agnostic antineoplastic agents Drugs developed by Bayer Orphan drugs Receptor tyrosine kinase inhibitors {{antineoplastic-drug-stub