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, 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 catalyt ...

. It was discovered by

Array BioPharma Array BioPharma is an American clinical stage, pharmaceutical company that focuses on oncology medication headquartered in Boulder, Colorado. The company is a subsidiary of Pfizer. History In 1998, the company was founded by Drs. Tony Piscopio, ...

and licensed to Loxo Oncology in 2013. Larotrectinib was initially awarded

orphan drug status An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...

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 " ...

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 used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast canc ...

, 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 federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA) considers it to be a

first-in-class medication A first-in-class medication is a pharmaceutical 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 medicat ...

. Phase II clinical trials evaluating the drug for efficacy and safety in treating several types of solid tumors are ongoing. Larotrectinib was approved for medical use in the European Union in September 2019. It was approved for medical use in Australia in August 2020.

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