Bayer has announced that the European Medicine Agency (EMA) has licensed its Vitrakvi (larotrectinib) in adults and children with solid tumours displaying Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion.
The indicated patients must also have either locally advanced or metastatic disease, or be in a situation where there are no adequate treatment options or surgical resection is likely to cause severe morbidity.
This makes Vitrakvi the first tumour agnostic drug to be approved in the European Union (EU), which means it can be used against multiple tumour types with the same, rare genetic alteration.
NTRK gene fusion occurs when the NTRK gene fuses with an unrelated gene, leading to an altered TRK protein, which has oncogenic drivers encouraging the spread and growth of cancer cells.
Bayer medical director Dr Brendon Gray commented: As the first tumour agnostic medicine approved in Europe, larotrectinib represents a real shift in cancer treatment.
“Larotrectinib offers new treatment options for adult and paediatric patients, some of whom have had not treatment options to date.”
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The EMA’s approval is based upon pooled data from 102 patients across three Phase I and II trials. The overall response rate was 67%, and the drug had a complete rate of 15% with 75% of patients still responding to treatment after one year.
In the pooled primary analysis set of 93 patients, Vitrakvi did not show either median duration of response or reach median progression free survival at the time of analysis.
Vitrakvi was well tolerated with only 3% of patients having to permanently stop therapy due to treatment-emergent adverse events.
Principal investigator of Phase I/II Scout paediatric trial and The Royal Marsden Hospital paediatric and adolescent oncology consultant Dr Julia Chisholm 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.”