FDA approves second ‘tissue agnostic’ cancer drug — Vitrakvi

By PharmaCompass

2018-11-29

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The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). Larotrectinib has been developed by Loxo Oncology and their partners at Bayer.

Stamford, CT-based Loxo is a trailblazer in personalized cancer therapies where patients are grouped not by the site of tumor development but by genetics.

This is the second time the agency has approved a cancer treatment based on a common biomarker across different types of tumors 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 its guidance document released earlier this year.

Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed following treatment.

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