FDA Aims to Approve More Drugs Based on Early Clinical Data

Agency would decide later if benefits were real or coincidental

The FDA is aiming to approve drugs based on very early data if the medication shows a possible benefit in terms of survival, the head of the agency told lawmakers at a House committee hearing.

Speaking before the House Committee on Energy and Commerce, FDA Commissioner Scott Gottlieb, MD, said the agency would approve such drugs quickly and figure out later whether the benefit seen was real or coincidental. He cited the FDA’s “accelerated approval” pathway as a potential blueprint, Reuters reports.

Accelerated approval allows the agency to approve drugs based on substitute measures of clinical benefit. For example, cancer drugs that cause tumors to shrink are considered likely to confer a meaningful clinical benefit, such as survival. The same principal could be applied to drugs which appear to increase survival in a small number of people, Dr. Gottlieb said. It could be determined later whether the benefit was statistically significant.

“Even though the observed benefit, in this case, is on a clinical endpoint—an early look at survival—and not a surrogate measure of benefit, we believe using an accelerated approval approach often could be valuable,” Dr. Gottlieb said.

He added that the agency was also working on a proposal to more quickly approve cancer drugs for additional types of cancer, Reuters reports. Currently, a company with a lung cancer drug would have to conduct randomized clinical trials comparing the drug to a placebo or comparator drug. The new proposal would allow approval in a second cancer based on a single arm study in which all patients receive the experimental treatment.

Dr. Gottlieb said the agency plans to issue guidance clarifying the circumstances in which such an approach would be appropriate.

Source: Reuters; November 30, 2017.

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