FDA Approves New Cancer Drugs Faster Than EMA
June 17th, 2022 // 10:15 pm @ jmpickett
The FDA is faster to approve new cancer drugs compared to the EMA or European Medicines Agency, according to a study released in JAMA Network Open last week.
Investigators at Imperial College London did a clinical study involving 90 cancer drugs that were approved by the FDA and EMA between 2010 and 2019. They looked at how long each cancer drug was reviewed by the agencies, when the medicines were turned in for market authorization, whether the drug got accelerated approval, if it got conditional marketing authorization and the approval date for each drug with the FDA and EMA.
The clinical investigators determined that most of the cancer drugs were approved by FDA before the EMA, and 85 drugs were approved in the United States first, while only four drugs were approved after the EMA.
After FDA approved a cancer drug, it took approximately 240 days for the drug to get an authorization by the EMA, research showed.
More new drug applications were turned into FDA first, or about 65 of them. In the United States, 35, cancer drugs were given FDA approval before major clinical studies were published, compared to only eight with the EMA.
Researchers also found that 30 drugs in the US got accelerated drug approval in the US and 23 got conditional marketing authorization in Europe. There were 15 drugs that got both FDA and EMA approval in an expedited manner. The median time for review for the US was 30 days shorter with the accelerated review, compared with regular drug authorization. The median review time in Europe was 55 days shorter when compared with standard authorization.
Twenty of 31 cancer drugs that got the accelerated approval in the US got full, regular drug approval later. Three were pulled and nine have accelerated approval status and clinical trial results are pending.
With the 23 cancer drugs that got conditional marketing authorization in Europe, 10 got regular drug approval, one was pulled, and 12 still are operating under conditional marketing authorization and clinical trial results are pending.
The researchers said the last 10 years have seen a lot of cancer drug authorizations in both Europe and the US. It’s vital that drug regulators on both continents do the most rigorous scientific review of new cancer drugs to make sure they are effective and safe.
It also should be noted that FDA may give more expedited cancer drug approvals, which gets therapies to patients faster. But this doesn’t mean the patients have superior outcomes in every case. Also, the speed of FDA review is getting better, but the number of cancer drugs that improve survival have not risen markedly in recent years.
