On 22 June 2023, 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 the third-line treatment of colorectal cancer (CRC) in combination with bevacizumab.
For information, the full indications for Lonsurf will therefore be as follows (new indication in bold):
Colorectal cancer
Lonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic CRC who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.
Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic CRC 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.