2023-06-24 09:50:46
The French pharmaceutical company, Servier, announced on Friday that it had received a positive opinion from the European Medicines Agency (EMA) regarding its drug, “Lonserve”, which is taken with an antibody to fight colorectal cancer, a disease that is difficult to treat.
The positive opinion of the Committee for Medicines for Human Use (CHMP) of the European Medicines Agency relates to the treatment of adult patients with colorectal cancer who had previously received two treatment protocols, including chemotherapy, but did not respond to either, Servier said in a statement.
The committee relied on the results of a global Phase 3 clinical trial in which the efficacy and safety of Lonserve (trifluridine/tiberacil) were compared when the patient took it without any additional medication, with the antibody bevacizumab.
The combination of the two drugs saw significant improvements in survival in patients with treatment-refractory colorectal cancer who had progressed or had not tolerated two previous chemotherapy protocols, compared to Lonserve alone, according to clinical data from this study.
Usually, the European Medicines Agency, which authorizes a drug to be put on the market, relies on the recommendations of the Committee on Medicines for Human Use within a period of up to two months.
“The imminent launch of the drug on the market is an important step in the treatment of this deadly disease, which is increasing in incidence in Europe and the rest of the world,” said Claude Bertrand, Vice President of Research and Development at Servier.
Colorectal cancer is one of the most common types of cancer following breast cancer and lung cancer.
It can be detected at an early stage through a fecal occult blood test.
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