Servier’s Lonsurf approved in advanced colorectal cancer in EU

Servier’s Lonsurf (trifluridine+tipiracil) has been approved in Europe for adults with metastatic colorectal cancer (mCRC), as the company seeks to increase its presence in oncology medicine.

The oral drug came to Servier through a deal with Japan’s Taiho Pharmaceutical last year, which gave the French company commercialisation rights in Europe, in return for a $130 million upfront fee, plus milestone and royalty payments.

Servier will also commercialise the combination in other countries outside the US, Canada, Mexico and Asia, with Taiho retaining development and commercial rights in the US, Canada, Mexico and Asia, and rights to manufacture and supply the product.

Servier has been attempting to increase its presence in oncology in recent years, and in 2013 partnered with US biotech Clovis for development of lucitanib in breast cancer. It followed this with a deal with Cellectis in 2014 to develop and market drugs for leukaemia and solid tumours.

The European Medicines Agency’s CHMP recommended a marketing authorisation for Lonsurf in mCRC in February.

Formerly known as TAS-102, approval was based on data from the phase 3 RECOURSE study, which showed patients in the treatment group had a median overall survival of 7.1 months, compared with 5.3 months in the placebo group.

An updated efficacy analysis of overall survival confirmed the clinically meaningful and statistically significant survival benefit, Servier said.

The most frequently observed side effects were neutropenia, nausea, fatigue, anaemia and leucopenia.

Lonsurf is now licensed in the 28 European Union member states, as well as Iceland, Lichtenstein and Norway.

Trifluridine/tipiracil is an oral combination anticancer drug of trifluridine (FTD) and tipiracil (TPI). Its primary mechanism of action differs from fluoropyrimidines, which means it is an option for patients resistant to fluoropyrimidines.

FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA of cancer cells, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD‐degrading enzyme, thymidine phosphorylase.

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