Access to potentially life-extending cancer drugs varies significantly in different regions of the world, two new studies show at the ESMO 2014 Congress in Madrid, Spain.

Researchers say the results demonstrate the need for better collaboration between doctors and health authorities on an international scale, to ensure patients have access to the best treatments.

Coordinated action is needed at an international level to ensure new cancer-fighting drugs are approved in a timely manner, oncologists said at the Congress. Their call came after a survey revealed that patients in some regions sometimes wait years longer than their counterparts elsewhere for new drugs to be approved.

The drug approval process is important to ensure that safe and effective therapies are made available for patients, explains study senior author Dr Sunil Verma from Sunnybrook Odette Cancer Center, Toronto, Canada.

To try and understand disparities in the drug approval time among various countries, Verma and coauthor Nardin Samuel compared approval times for 41 cancer drugs in Canada, the USA and the European Union.

They found that the average time to approval for these drugs by the US Food and Drug Administration (FDA) was 6 months shorter than for the European Union’s European Medicines Agency (EMA) and 7.6 months faster than Health Canada.

Azactidine, for example, approved for haematological malignancies, had the greatest delay between FDA and Health Canada approval, stretching to 66.1 months.

The EMA approved azactidine 10.3 months earlier than Health Canada but 55.8 months after the FDA.

The fastest approval time among the drugs studied was for cabazitaxel, which was approved for metastatic prostate cancer by the FDA just 17 days after the drug’s manufacturer filed for approval.

In Canada and Europe, the times to approval for cabazitaxel were 11.63 months and 11.03 months, respectively.

This is the first study to systematically compare cancer drug approvals between three major regulatory bodies, the authors say.

While approval from regulatory agencies plays an important part in helping ensure the safety and efficacy of new drugs, delays in the approval process can have an impact on patient care, they note.

“Our main aim as clinicians is to ensure that patients are given an opportunity to receive proven, effective and safe treatment in a timely manner. We need to balance due diligence to review appropriate treatment by regulatory agencies and providing treatment to our patients that is effective,” Verma says.

“There needs to be a dialogue amongst industry, regulatory agencies, patient bodies, research community and oncology professionals on how best we can reduce the time to approval while ensuring safety for approved drugs. We also need a coordinated international approach to reduce the disparity in time to access new drugs around the world.”

Commenting on the study, Professor David Cameron, director of the Edinburgh Cancer Research Centre, UK, noted: “This interesting study compares the times to regulatory approval in USA, Canada and Europe. There was little difference overall between the approval times for the EMA (Europe) and Health Canada, but both of these agencies approved new anti-cancer agents significantly later than the FDA in USA. Interestingly one drug, carbazitaxel, was approved in under 1 month in the USA.”

“It is not clear why there were these differences, but they are of some concern in the sense that they suggest that in the absence of data to the contrary, there may be bureaucratic rather than medical/scientific reasons for differential geographical approval timelines – which of course will lead to differential geographical benefits from new agents,” Cameron said.

Clearly more work is needed to understand the reasons for these differences, and any potential patient impact, but this work should stimulate such deeper investigations, Cameron said.

Source: ESMO