On July 26, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended Bayer’s precision oncology treatment Vitrakvi (larotrectinib) for marketing authorisation in the EU.

Precision oncology treatment

Vitrakvi’s recommended indication is for the treatment of adult and pediatric patients with solid tumours that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, with a disease that is locally advanced, metastatic, or where a surgical procedure can result in severe morbidity and patients have no satisfactory treatment options. While the positive CHMP decision does not guarantee an EMA approval, GlobalData expects that the EMA will likely agree with the CHMP decision and that Vitrakvi will receive EMA approval in several months.

If approved, Vitrakvi will be the first-in-class tropomyosin receptor kinase (TRK) inhibitor specifically developed to treat tumours that have an NTRK gene fusion and will be the first treatment to receive a tumour-agnostic indication in the EU. On November 26, 2018, Vitrakvi was given FDA approval after it received accelerated approval. Accelerated approval allows the FDA to approve drugs indicated for serious conditions to fill an unmet need based on clinical trial data. Vitrakvi has also been approved in Canada and Brazil.

The positive CHMP decision comes after three positive clinical trial readouts. The trials included 55 pediatric and adult patients who had solid tumours that had an identified NTRK gene fusion, did not have a resistance mutation and were metastatic, or where surgical resection was likely to result in severe morbidity. Vitrakvi demonstrated a 75% overall response rate across different types of solid tumours. These responses were durable, with 73% of responses lasting at least six months and 39% lasting one year or more at the time the results were analysed.

GlobalData expects sales for Vitrakvi to be high in the EU as it is the first-in-class tumour-agnostic drug approved in this region. Additionally, Vitrakvi has recorded estimated sales of $67 million thus far in 2019, and GlobalData expects its US sales to increase $846 million by 2025 based on Vitrakvi’s impressive clinical profile.