US clears Loxo Oncology, Bayer's Vitrakvi for tumours driven by NTRK gene fusion, regardless of location

The FDA announced Monday that it granted accelerated approval for Loxo Oncology and Bayer's Vitrakvi (larotrectinib) to treat adult and paediatric patients whose cancers have a receptor kinase that promotes tumours. Specifically, the drug is indicated for solid tumours that have NTRK gene fusion without a known acquired resistance mutation, are metastatic or likely to result in severe morbidity if surgically resected, and have no satisfactory alternative options or have progressed following treatment.

FDA Commissioner Scott Gottlieb remarked "today’s approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body," adding "we now have the ability to make sure that the right patients get the right treatment at the right time."

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