When a new drug is marketed, logic would like it to work better than previous one. However, this is far from case for most of anti-cancer drugs allowed between 2009 and 2013, according to a study published in journal British Medical Journal.
"Our results suggest that it is extremely rare for new cancer drugs to be effective on two most important aspects to patients: improving ir survival and quality of life," concluded authors of study , published on 4 October.
They found that at time of green light of European Medicines Agency (EMA)-Issuing AMM (marketing authorisation)-only 29 of 68 new treatments (i.e. 43%) provided significant evidence of an improvement in relation to Medications used so far, regarding lifespan or quality of life of patients. After a few years of use (three to eight years depending on products), six or treatments finally proved useful in se two areas, bringing number of effective products to 35 (51% of treatments).The European agency not rigorous?
Contacted by Figaro, EMA, who said that she had "learned study", defended herself by emphasizing that assessments of cancer drugs "take into account a wide range of measures, including survival and improvement of quality of life." But y also include progression-free survival (i.e., period during which cancer does not worsen), response rate (e.g. shrinking tumor size), and finally, length of response.
And this is problem in evaluation of EMA, according to Pr Christophe le Tourneau, responsible for early clinical trials and precision medicine at Institut Curie. "In ory, only relevant criteria are improving quality and life expectancy," he explains. The British researchers conclude that ir results should lead European Medicines Agency to "revise its criteria for approval of anti-cancer treatments."
"It is true that health authorities may lack rigour in ir assessments, and that some medicines should not be allowed because y are not very effective," confirms Dr. Frédéric Patel, president of French Society of Oncology Pharmacy.Difficult studies
"However, it is not always so simple," tempers Pr Christophe le Tourneau. Indeed, when a drug is suspected of functioning in clinical trials, it is n given, for ethical reasons, to all patients who participated in trial, "making assessment of improvement of difficult survival."
Moreover, "medications that add years of life to patients do not happen every day," says Christophe Le Tourneau, taking example of trastuzumab, which has revolutionized treatment of breast cancer. Dr. Patel recalls that drugs, which have "at first glance modest results", can, in combination with or treatments, significantly improve lives of patients.
"For drugs that only earn a few weeks of survival on average, re are often some patients who actually gain much more in midst of a majority who do not benefit at all," "Tourneau," Question is to know where to put cursor. '