EMA Recommends Extension of Indications for Trifluridine/Tipiracil

Changes concern adoption of a new indication for gastric cancer and a change to the existing indication for colorectal cancer
30 Jul 2019

On 25 July 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product trifluridine/tipiracil (Lonsurf).

The marketing authorisation holder for this medicinal product is Les Laboratoires Servier.

The CHMP adopted a new indication for gastric cancer and a change to the existing indication for colorectal cancer. The full indications for Lonsurf will now be as follows (new text in bold):

Colorectal cancer

Lonsurf is indicated as monotherapy 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.

Gastric cancer

Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastro-oesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

Last update: 30 Jul 2019

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings