German pharmaceutical and life sciences company Bayer has secured approval from the European Commission to market its oncology treatment Vitrakvi (larotrectinib) in European Union (EU).

Vitrakvi is intended for the treatment of adult and paediatric patients with solid tumours presenting Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, locally advanced disease, metastasis, and patients with no satisfactory treatment options.

Bayer’s pharmaceuticals division executive committee member and oncology strategic business unit head Robert LaCaze said: “The approval of Vitrakvi in the EU, a first-of-its-kind treatment exclusively designed for adults and children with TRK fusion cancer, represents a meaningful advancement in the fight against cancer, as it treats the oncogenic driver that causes tumour spread and growth, rather than where the tumour originates in the body.

“Cancer care is currently undergoing a paradigm shift and as this new era of precision oncology treatment unfolds, we are continuing our effort of delivering innovative medicines such as Vitrakvi, which can provide value to patients and their treating physicians around the world.”

Vitrakvi provides high response rates and durable responses in adults and children with TRK fusion cancer

According to the company, TRK fusion cancer is a rare disorder that affects both children and adults and occurs due to fusion of NTRK gene with another unrelated gene, producing an altered TRK protein.

Vitrakvi, a first-in-class oral TRK inhibitor exclusively designed to treat tumours that have an NTRK gene fusion, is the first treatment in the EU to receive a tumour-agnostic indication.

Vitrakvi has demonstrated high response rates and durable responses in adults and children with TRK fusion cancer, including central nervous system (CNS) tumours. It is already approved in the US, Brazil and Canada.

Bayer said that the approval of Vitrakvi is based on pooled clinical trial data of 102 patients across the Phase I trial of adult patients, Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II paediatric SCOUT trial.

Results from the clinical studies showed an overall response rate (ORR) of 72%, including 16% complete responses (CR) and 55% partial responses (PR).

In addition, the safety of the drug was evaluated in 125 patients with an NTRK gene fusion, and the results showed a positive safety profile, with the majority of adverse events (AEs) being grade 1 or 2.