European regulators have cleared Bayer's Vitrakvi (larotrectinib) as a treatment for solid tumours displaying an NTRK gene fusion.
The decision allows physicians to prescribe the drug for patients whose condition is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.
The approval rides on the back of clinical data showing that larotrectinib was linked with an overall response rate of 72%, including 16% complete responses, with 75% of patients still on treatment after one year.
“With this first-ever tumour-agnostic approval in the EU, physicians in Europe now have the option to replace less tailored treatment approaches with a precision oncology treatment exclusively designed to treat tumours that have an NTRK gene fusion – a rare cancer which affects both children and adults and occurs in varying frequencies across various tumor types,” said Prof. Jesus Garcia-Foncillas, director of the University Cancer Institute and the Department of Oncology at the University Hospital Fundacion Jimenez Diaz.
“Existing therapies commonly used to treat TRK fusion cancer patients such as chemotherapy or immuno-oncology therapies have shown limited efficacy, and may have significant side effects. With Vitrakvi, we have seen rapid, robust and durable responses with a consistent and manageable safety profile in patients with TRK fusion cancer, regardless of the age of the patient or where in the body the tumour is located.”
Bayer obtained exclusive licensing rights or the global development and commercialisation of larotrectinib and the investigational TRK inhibitor BAY 2731954 (previously LOXO-195) after Lilly acquired Loxo earlier this year.