France-based pharmaceutical firm Servier Laboratories, along with its partner Taiho Pharmaceutical, 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.

LONSURF is indicated for patients diagnosed with adenocarcinoma of the gastroesophageal junction, and have been previously treated with at least two prior systemic treatment regimens.

Servier said that the marketing approval is based on data from the global Phase III trial TAGS, a randomized, double-blind study of LONSURF.

TAGS pivotal Phase III trial European lead Josep Tabernero said: “The approval of trifluridine/tipiracil is a landmark decision for patients across the European Union (EU). 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.”

Phase III trial TAGS showed positive results of LONSURF

Phase III trial TAGS is designed to evaluate LONSURF along with best supportive care (BSC), with placebo plus BSC, in patients with metastatic gastric cancer refractory to standard treatments.

According to the study results, LONSURF showed statistically significant improvement in overall survival compared to placebo plus BSC.

The patients treated with LONSURF and BSC showed a 31% reduction in risk of death, and the overall safety profile was consistent. The known safety profile of LONSURF in metastatic colorectal cancer (CRC) showed hematological adverse events.

The company said that the present approval decision follows the indication of LONSURF in the EU, indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer, and have been previously treated with available therapies.

Servier oncology research and development head Patrick Therasse said: “We are very pleased with today’s approval of LONSURF, metastatic gastric cancer is difficult to treat and it’s important that clinicians are able to access a range of treatment options.

“We will now work with health technology assessment bodies across Europe to enable access for eligible patients to LONSURF as quickly as possible.”