FDA Granted Accelerated Approval to Vitrakvi (Larotrectinib) in November 2018

In November 2018, the Food and Drug Administration (FDA) initially granted accelerated approval to Vitrakvi, also known as larotrectinib. This marks a significant step in the drug’s regulatory journey. The FDA’s decision to grant accelerated approval indicates that the drug met the necessary requirements at the time, based on available data. This pathway allows for earlier approval of drugs that address serious conditions and fill an unmet medical need, while further studies are conducted to confirm the drug’s clinical benefit.

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Date: April 14, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後