Servier and Taiho have announced that the European Commission (EC) has approved the use of Lonsurf (trifluridine/tipiracil) as monotherapy for the treatment of adult patients with metastatic gastric cancer.
The indication includes patients with adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
The decision extends the indication of Lonsurf in the European Union, which is already indicated as monotherapy for the treatment of certain adult patients with metastatic colorectal cancer.
The decision was made based on data from the global Phase III TAGS trial, which demonstrated a statistically significant improvement in overall survival (OS) of 5.7 months compared to 3.6 months for placebo.
The trial also found that there was a 31% risk reduction of death.
The approval is a “landmark decision for patients across the European Union,” said Professor Josep Tabernero, European lead of the TAGS trial.
He continued to say that “The data from the global TAGS trial supports trifluridine/tipiracil as an efficacious and tolerable therapy for patients with refractory metastatic gastric cancer. Before today there has been no approved standard of care for this population of poor-risk patients who had already progressed on previous therapies, meaning this is a step forward for patients who previously had limited treatment options.”
Gastric cancer in Europe affects approximately 130,000 people a year, and causes over 100,000 deaths a year. Symptoms for the disease can be vague and it is estimated that over 40% of gastric cancer patients will have metastatic disease at the time of diagnosis.