EU approves treatment for advanced metastatic colorectal cancer3 May 2016
The European Commission (EC) has granted marketing authorization for combined trifluridine/tipiracil , formerly known as TAS-102, in the European Union (EU) for the treatment of adult patients with metastatic colorectal cancer (mCRC).
The approval applies to the treatment of patients 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.
A phase 3 study showed improvement in overall survival
The decision from the EC follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of the combination in February 2016.
Both the CHMP opinion and the EC decisions were based on data from the RECOURSE study. RECOURSE is an international, double-blind, placebo-controlled Phase 3 study, which investigated the efficacy and safety of combined trifluridine/tipiracil with BSC compared to placebo with best supportive care (BSC) in 800 patients with previously treated mCRC, among which 403 were treated in Europe.
The study met the primary endpoint of statistically significant improvement in overall survival (OS). In particular, the results demonstrated:
- A 32% reduction in risk of death compared to BSC.
- An updated overall survival analysis in 89% of events confirmed the clinically meaningful and statistically significant survival benefit compared to placebo with BSC. This translates into a 31% relative reduction in the risk of death and an improvement of 2 months in the median overall survival.
- The median overall survival for patients receiving the treatment was 7.2 months vs 5.2 months for placebo with BSC, this translated into 1-year survival rates of 27.1% and 16.6%, respectively.
The most frequently observed side effects (≥ 30%) were neutropenia, nausea, decreased appetite, diarrhea, fatigue, anemia, thrombocytopenia, an increase in total bilirubin, alkaline phosphatase and ASAT levels, and leucopenia.
The combination of trifluridine and tipiracil works by directly attacking the DNA
“Data from the pivotal RECOURSE study provides evidence that combination trifluridine/tipiracil may offer patients with refractory metastatic colorectal cancer extended survival as well as a reduction in risk of death compared to placebo,” said Professor Eric Van Cutsem, MD, PhD, Digestive Oncology, University Hospitals Leuven in Belgium.
“The combination of trifluridine and tipiracil works by directly attacking the DNA of the tumor cells which reduces the growth of cancer cells. 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.”
“With this approval, we are delivering on a promise to bring a new treatment to patients with advanced metastatic colorectal cancer across Europe,” said Dr. U. Marion Schrenk, Head of Global Medical Strategy, Oncology at Servier, which markets trifluridine/tipiracil as Lonsurf. “[It] has also been shown to prolong progression-free survival and preserve performance status, allowing patients to make time for more moments that matter.”
Source: eCancer News