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NTRK gene fusion

9/2/2019

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There are two drugs approved by the FDA for the treatment of cancers that have NTRK gene fusions.

On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

On August 15, 2019, the Food and Drug Administration granted accelerated approval to entrectinib for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor 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 progressed following treatment or have no satisfactory standard therapy.


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    Joseph Kim, MD, MPH, MBA is President of Q Synthesis LLC.
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