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Published on 25 September 2019

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First tumour-agnostic treatment licensed in Europe

The European Commission has granted conditional EU marketing authorisation for Bayer’s targeted oncology treatment larotrectinib (Vitrakvi®).

The drug is indicated for the treatment of adult and paediatric patients with solid tumours that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.

Dr Julia Chisholm, Consultant in Paediatric and Adolescent Oncology at The Royal Marsden Hospital and Principal Investigator for the ongoing SCOUT study to test the safety and efficacy of the drug larotrectinib for the treatment of tumours with NTRK-fusion in children, commented: “Larotrectinib’s EMA licencing marks another step towards treating cancers based on tumour genetics rather than site of origin in the body. Treatment with larotrectinib, which is designed specifically for the NTRK fusion oncogenic driver, can deliver clinically meaningful responses in patients with cancers which otherwise remain challenging to treat. We are delighted that clinicians managing such patients will now have a medicine licenced to specifically treat tumours with an NTRK gene fusion.”

The EMA licencing of larotrectinib is based on pooled clinical trial data of 102 patients (93 patients from the primary analysis population and an additional nine patients with primary CNS tumours) across the Phase I trial of adult patients, the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II paediatric SCOUT trial.

Larotrectinib was investigated in clinical trials across 29 different histologies of solid tumours including lung, thyroid, melanoma, gastrointestinal stromal tumours, colon, soft tissue sarcomas, salivary gland and infantile fibrosarcoma. The compound has shown efficacy in primary CNS tumours, as well as patients with brain metastases, across age or tumour histology.

Dr Brendon Gray, Medical Director at Bayer, said: “As the first tumour agnostic medicine licenced in Europe, larotrectinib represents a real shift in cancer treatment and creates an opportunity for the UK to demonstrate it is at the forefront of genomic medicine. Larotrectinib offers new treatment options for adult and paediatric patients, some of whom have had not treatment options to date.”



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