FDA approves larotrectinib for any NTRK tumor, but NHS says "no"

NTRK Fusion Drug Not Cost Effective for Tumor-Agnostic Use, UK's NICE Suggest

Jan 17, 2020

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NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) has issued a new draft report recommending against the histology-independent use of larotrectinib (Bayer's Vitrakvi) for advanced adult and pediatric cancer patients treated through the National Health Service (NHS), even for rare cancer types or when no other satisfactory treatment options exist.

At the request of the UK's Department of Health and Social Care, NICE undertook an appraisal consultation on the use of larotrectinib — a drug that targets tumor specific fusions involving the tyrosine receptor kinase enzyme-coding gene NTRK. Under current conditional marketing authorization from the European Medicines Agency, larotrectinib can be used to treat NTRK fusion-positive solid tumors in adults or children with locally advanced, metastatic, or non-surgically resectable cancer cases without appropriate treatment alternatives.....

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FDA approves larotrectinib for solid tumors with NTRK gene fusions

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Listen to the FDA D.I.S.C.O. podcast about this approval

On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI, Loxo Oncology Inc. and Bayer) 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.

This is the second tissue-agnostic FDA approval for the treatment of cancer.

This indication is approved under accelerated approval and continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.FDA granted this application priority review, breakthrough therapy designation and orphan product designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.