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02-05-2011 | Oncology | Article

Half of cancer drug approvals differ between US and Europe


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MedWire News: European researchers have identified clinically relevant differences in the outcome of oncology drug approval processes between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA).

"In some cases, such differences significantly affect patients' access to relevant therapeutic options," report Giovanni Tafuri (Italian Medicines Agency, Rome) and colleagues.

The researchers used data from the European Public Assessment Reports and FDA review reports to compare the approaches of the two agencies in the evaluation and approval of new anticancer indications, and to identify possible clinical implications associated with any differences encountered.

In total, 42 anticancer drugs were approved by the EMA between 1995 and 2008, corresponding to a total of 100 indications for the treatment of tumors or malignancies.

Of these, 47 therapeutic indications showed a difference between the two agencies. In three cases, an FDA indication was not approved by the EMA, and in 16 cases, the FDA did not approve an EMA indication.

The remaining 28 indications had different wording of the label, including 10 cases in which the difference had a significant clinical meaning for patients.

For example, Tafuri and team found that in the European Union, temsirolimus is indicated for the first-line treatment of advanced renal cell carcinoma only for patients who have at least three of six prognostic risk factors. In contrast, the same drug is indicated for all patients with advanced renal cell carcinoma in the USA.

In spite of the differences, the researchers say that neither of the agencies appeared to have a prevailing restrictive behavior over the other, but there was a trend for the agency that was second to give a positive approval to be more restrictive in terms of wording of the indication, compared with the agency that provided approval first.

"A critical finding of this analysis lies in those indications approved only by one of the two agencies," write Tafuri and co-authors in the Journal of Clinical Oncology.

"This means that large patient populations may be deprived of treatments that are available in other countries, or that patients who live in the countries where the drug is available could be exposed to drugs whose benefit-risk profile was not considered positive elsewhere."

The researchers conclude by calling for further efforts to harmonize decision making between regulatory systems.

MedWire ( is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011

By Laura Dean

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