It is essential to speed up the process of licensing new cancer drugs so that patients can benefit more quickly from novel treatments, cancer specialist Dr Luca Gianni told a Brussels news conference today. (Thursday 28 September)
Current procedures are justified to make sure that new drugs have real merits, but they are often too slow to cope with the surge of new treatments for breast cancer coming out of research laboratories of academic institutes and pharmaceutical companies, he said.
"The wealth of new treatments, such as signal transduction drugs, anti-angiogenics, chemotherapeutics and hormonal therapies, is generating a problem - how to ensure the quickest reliable evaluation and commercial availability," Dr Gianni told the briefing at the European Breast Cancer Conference.
Current procedures for approving drugs which had been evaluated in clinical trials were long and cumbersome, he said. In Europe the European Medical Evaluation Agency (EMEA) works along lines similar, but not identical, to the Food and Drugs Administration (FDA) in the United States. After European evaluation individual countries then also had to give commercial approval.
"It is unfortunate that there is duplication between the USA and Europe. However, the problem is recognised and discussions are now under way between regulatory agencies about harmonising the process. This would avoid unnecessary duplication and shorten the interval between the establishment of a new compound as an active and favourable drug and its availability in everyday practice," he said.
Turning to another area of research - the use of new biological prognostic tools to identify different sub-types of breast cancer - Dr Gianni, who is head of the Medical Oncology Division at the Instituto Nazionale Tumori in Milan, urged oncologists to exercise a certain amount of caution.
"With specific prognostic factors, such as HER2 over-expression, becoming the target for tailored therapies, their value as prognostic factors switches from prognosis towards that of predictor of response to certain treatments.
"This trend is growing fast and will eventually lead to individual tailoring of treatments, in contrast to the current empirical approach by which the same treatment is given to all patients of the same broad risk category although we know that some may not need it because they are already cured by surgery and that others may not benefit because they have tumours resistant to that treatment.
"Although tailoring therapy to the individual, thus optimising the chances of cure and avoiding unnecessary treatment, is the ultimate goal and challenge, we still have a long way to go. Until the time comes that we have firm data to support or contra-indicate the administration of a specific therapy to individual patients, we must not deny standard treatments to anyone based solely on unconfirmed hypotheses."
Note: after 30 September, Mary and Kay are available at 32-2-775-0203