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news.The European Commission (EC) has granted marketing authorization for Taiho Pharmaceutical's Lonsurf (trifluridine/tipiracil), formerly known as TAS-102, to treat advanced metastatic colorectal cancer (mCRC).
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Lonsurf is indicated to treat adult patients with mCRC who have earlier been treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
French independent research-based pharmaceutical firm Servier will co-develop and commercialize Lonsurf in the European Union countries under a license agreement with Taiho Pharmaceutical.
The EC’s decision was based on data from the pivotal Recourse study, which provides evidence that Lonsurf may provide patients with refractory metastatic colorectal cancer extended survival and a reduction in risk of death compared to placebo.
The study evaluated the efficacy and safety of Lonsurf with best supportive care (BSC) compared to placebo with BSC in 800 patients with previously treated mCRC.
Results showed a 32% reduction in the risk of death compared to BSC. The median OS was 7.2 months for Lonsurf with BSC vs 5.2 months for placebo with BSC.
Lonsurf is currently available in Japan to treat unresectable advanced or recurrent CRC and in the US for the treatment of patients with mCRC who have been earlier treated with fluoropyrimidine -, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.