| Developers: | Bayer AG |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
2022: Registration in Russia
At the end of June 2022, Bayer received in Russia a registration certificate of the Ministry of Health for the antitumor drug Vitrakvi (INN larotrectinib).
As the publication "Pharmaceutical Bulletin" writes, "Vitrakvi" is a "universal" drug against cancer. It targets a key genetic factor in tumor growth. The drug is indicated for the treatment of adults and children with solid tumors when detecting a specific genetic trait - fusion of genes of the neurotrophic tyrosine kinase receptor (NTRK). The instructions also indicate that the drug is indicated in the metastatic process or when surgical removal of the tumor can lead to severe complications, or when patients do not have adequate treatment options. "Vitraqui" is registered in the form of capsules of 25 mg and 100 mg.
The efficacy and safety of the drug have been studied in three multicenter clinical studies. Larotrectinib showed a 75% overall response rate in various solid tumors. 73% had a duration of response of at least six months, 39% had a year or more.
Participants who entered clinical studies were diagnosed with the following oncological diagnoses: soft tissue sarcoma, salivary glands cancer, infantile fibrosarcoma, thyroid cancer, lung cancer, melanoma, colon cancer, gastrointestinal stromal tumor, cholangiocarcinoma, appendix cancer , breast cancer, pancreatic cancer. In 82% of patients, the disease was at the metastatic stage, in 18% - locally advanced inoperable.
The purpose of Vitrakvi accompanies the increased risks of neurotoxicity, hepatotoxicity and embryofetal toxicity.
By June 2022, two clinical trials of larotrectinib are ongoing in Russia. They should be completed in 2025-2026[1]
Notes
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