Study: FDA approves new oncology drugs quicker than EMA

Regulatory NewsRegulatory News | 10 June 2022 |  By 

The US Food and Drug Administration (FDA) is quicker to approve new oncology drugs compared with the European Medicines Agency (EMA), according to a study published 10 June in JAMA Network Open.
Mark P. Lythgoe, MBBS, of Imperial College London, and colleagues performed a cross-sectional study of 89 oncology drugs that were approved in the US and Europe between 2010 and 2019, analyzing how long each drug was reviewed, when the drug was submitted for marketing authorization, whether it had received accelerated approval or conditional marketing authorization, and the drug’s regulatory approval date with each agency.
The investigators found nearly all oncology drugs evaluated were approved in the US before Europe, with 85 oncology drugs (95%) approved first in the US and 4 drugs (5%) approved after Europe. After the US approved an oncology drug, it took a median of 241 days (IQR, 150-370 days) for the same drug to be authorized in Europe, according to the research.
Most licensing applications for the oncology drugs were submitted to FDA first (64 applications or 72%). In the US, 34 oncology drugs (39%) were approved prior to the publication of pivotal trial results, compared with 8 (9%) in Europe.
When comparing the number of oncology drugs that were approved under expedited pathways, the researchers found 31 drugs (35%) had received accelerated approval by the FDA and 23 drugs (26%) had received conditional marketing authorization by the EMA. There were 15 therapies (19%) that were approved by both FDA and EMA concurrently under expedited pathways. The median review time for FDA was 31 days shorter under accelerated approval compared with regular authorization, while the median review time for EMA was 56 days shorter compared with regular authorization.
Ultimately, 19 of 31 oncology drugs (61%) that received accelerated approval from FDA went on to receive regular approval. Three (16%) were withdrawn and nine (27%) currently have accelerated approval status with confirmatory trial results pending.
Among the 23 oncology drugs that received conditional marketing authorization from EMA, 10 (43%) received regular approval, one (4%) was withdrawn, and 12 still have conditional marketing authorization status with confirmatory trial results pending.
“The past decade has seen record numbers of new oncology therapy authorizations in the US and Europe. It is critical that medicine regulators undertake rigorous scientific review of all new therapies to ensure efficacy, safety, and public confidence in cancer medicines,” Lythgoe and colleagues wrote.
While expedited approvals by the FDA in oncology may seem appealing because it brings drugs to patients quicker, “faster review times have not always translated into better outcomes,” Kristina Jenei, BSN, MSc, of University of British Columbia in Vancouver, wrote in an invited commentary on the study, also published 10 June in JAMA Network Open.
“Although the speed of FDA review times and subsequent number of approvals have increased over time, the proportion of cancer drugs that improve survival has declined. Furthermore, although other countries approve fewer medicines than the US, available therapies tend to offer more benefit to patients,” Jenei wrote.
Jenei and her colleagues recently performed an analysis that showed 48 of 78 drugs (61.5%) recommended by the pan-Canadian Oncology Drug Review between 2011 and 2020 demonstrated clinical benefit compared with 46 of 105 (43.8%) drugs approved by FDA over the same timeframe.
Jenei also noted that more drugs under accelerated approval in the US were withdrawn compared with Europe. “These findings could be interpreted positively; that the system is working as it should. However, the FDA’s inconsistent follow-up of postmarketing studies leaves a substantial proportion of cancer drugs approved through accelerated pathways on the market for years without confirmation of their benefit,” she said.
Further, the use of surrogate endpoints in trials for oncology drugs under accelerated approval in the US “lowers global standards for testing and creates a culture of widespread drug access that impose challenges on other countries to obtain the evidence they need for appropriate drug coverage decisions,” Jenei noted. “The impact of these FDA practices on other countries are underappreciated.”
“Regulatory agencies have the difficult task of balancing earlier patient access to novel treatments and ensuring therapies are effective and safe. However, faster review times and approvals are not cause for celebration; better patient outcomes are. In other words, quality over quantity,” she wrote.
Study (open access)
Invited Commentary (open access)


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