Dr. Pazdur Speaks out on Cancer Trials and Accelerated Approvals

So a lot of investors have been wondering what will happen to cancer drugs that are in the Accelerated approval process because of the recent fiasco surrounding Avastin. For those that don’t know the story, Avastin is a drug for breast cancer that has had significant setbacks. The drug was approved under the FDA’s coveted Accelerated Approval Process. Accelerated approvals allow drugs to get an FDA approval by using what is known as a surrogate endpoint. Usually the surrogate endpoint is used as an indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Recently the FDA held an Advisory hearing to decide whether Avastin should stay on the market. The company was required to run to confirmatory trials to help bolster the drug after it had already been on the market. But the two trials actually ended up showing that the drug was not in fact working as intended.

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