26 November 2018 - The U.S. FDA today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and paediatric patients whose cancers have a specific genetic feature (biomarker).

This is the second time the agency has approved a cancer treatment based on a common biomarker across different types of tumours rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic.” It follows the policies that the FDA developed in a guidance document released earlier this year.

The efficacy of larotrectinib was studied in three clinical trials that included 55 paediatric and adult patients with solid tumours that had an identified NTRK gene fusion without a resistance mutation and were metastatic or where surgical resection was likely to result in severe morbidity. These patients had no satisfactory alternative treatments or had cancer that progressed following treatment.

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