Servier’s Lonsurf has been cleared for use in Europe to treat certain patients with metastatic colorectal cancer.
The European Commission has approved the drug for adults patients with the condition who have been previously treated with, or are not considered candidates for, available therapies including certain chemotherapies, anti-VEGF agents, and anti-EGFR agents.
Lonsurf (trifluridine/tipiracil, formerly TAS-102) combines an anticancer drug called trifluridine, which interferes with DNA function, with tipiracil hydrochloride, which maintains blood concentration of the former.
“This approach fights the cancer differently to other previously given treatments, allowing us to delay cancer progression rather than cycling back through therapies that have already been used,” noted Professor Eric Van Cutsem, Digestive Oncology, University Hospitals Leuven in Belgium.
Data from the Phase III RECOURSE trial have shown a significant improvement in overall survival in patients taking Lonsurf, with a reduction in the risk of death 32% compared to best supportive care.
On the downside, the drug did cause severe and life-threatening myelosuppression (a severe decrease in blood cell and platelet production), consisting of anaemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3.8%), while one patient died from neutropenic infection.
The approval follows a positive recommendation by the European Medicine Agency’s Committee for Medicinal Products for Human Use back in February, while the drug was cleared in the US in September.