Study: FDA beats EMA on new cancer drug approvals

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It's a common belief among physicians and cancer patients that Europeans usually get the first shot at a new oncology drug, with Americans often waiting a considerable spell before the FDA follows up with an approval. But a new study in Health Affairs says that assumption is just plain wrong.

Investigators from Friends of Cancer Research--a cancer research think tank--crunched the numbers on 23 cancer drugs OK'd in both the U.S. and Europe and found that each debuted in the U.S. first. And the FDA, often criticized for being slow--consider the delay on Provenge or its unwillingness to review Roche's application on T-DM1--actually took only half the time European regulators required for an approval. At the EMA an application took an average of 350 days to review ahead of an approval compared to about half that in the U.S.

Regulators don't always agree on a drug though. The researchers note that three cancer drugs were approved in Europe but the FDA has approved 9 that didn't reach Europe. FDA commissioner Margaret Hamburg said that the results "reflect FDA's commitment to foster access to effective therapies in a responsive and timely manner."

The researchers noted that there were some limitations, noting that they only looked at the initial drug applications and not any delays developers may have experienced before they filed. And they also noted that U.S. and European regulators have been collaborating on their expectations for clinical trials, to help streamline the development process.

- see the study in Health Affairs
- here's the story from Reuters

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