Lonsurf (trifluridine;tipiracil)
- Region
- 🇪🇺 EU
- Active substance
- trifluridine;tipiracil
- Company
- Les Laboratoires Servier
- Status
- Authorised
- Therapeutic area
- Colorectal Neoplasms
- CHMP opinion
- Thu 25 Feb 2016
- EU approval
- Mon 25 Apr 2016
- Application
- EMEA/H/C/003897
- ATC
- L01BC59
- Official record
- www.ema.europa.eu
Indication
Colorectal cancer Lonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (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 colorectal cancer (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 gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
Regulatory milestones
No milestones recorded in the last year.
Follow Lonsurf
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.