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The CHMP’s opinion will now be sent to the European Commission for the adoption of the decision.
Gastric cancer in Europe affects approximately 130,000 people a year, and it is estimated that 40% of those patients will have metastatic disease. For those with advanced or metastatic disease the treatment options are limited and are often palliative.
“The positive opinion from the CHMP for Lonsurf is very welcomed; patients with metastatic gastric cancer have few therapeutic options remaining, so it is of the upmost importance new therapies are made available. The Phase III trial TAGS demonstrated that Lonsurf was effective and tolerable for these patients and gave patients valuable months of life,” said Professor Josep Tabernero, Head of the Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona and Director of the Vall d’Hebron Institute of Oncology (VHIO).
The marketing authorisation application was supported by data from the global Phase III trial TAGS (TAS-102 Gastric Study) which was a randomised, double-blind study evaluating Lonsurf, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. Lonsurf demonstrated significant improvement in overall survival (OS) (HR=0.69 [95% CI 0.56-0.85], p=0.00029) compared to placebo plus BSC. The median OS in patients treated with Lonsurf and BSC was 5.7 months compared to 3.6 months when treated with placebo and BSC, and there was a 31% risk reduction of death. The overall safety profile was consistent with the known safety profile of Lonsurf in metastatic colorectal cancer (CRC), with mainly haematological adverse events reported.
“Today’s announcement is one step closer to ensuring patients with metastatic gastric cancer have another treatment option, bringing an incremental survival benefit over the standard of care,” said Patrick Therasse, Head of Servier Research and Development Oncology. “Gastric cancer is difficult to treat and each step forward is a major event.”
Currently in the EU, Lonsurf is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.