Press release | 31st May 2023

The FDA is tightening requirements on accelerated approvals in oncology. Have biotechs the most to lose?

What is accelerated approval and why is it important?

Accelerated approval allows drugs to be approved with a surrogate endpoint, such as tumor shrinkage. If approval is accelerated, confirmatory data on survival are needed, so the drug can remain on-market.

FDA wants no delays to confirmatory trials being initiated

It takes a median of 7.3 years for an oncology drug to be withdrawn from the market if a confirmatory trial doesn’t go to plan – this was the FDA’s argument for pushing for a re-vamp of the accelerated approval process.

The FDA wants confirmatory data faster

As per new FDA draft guidance, the FDA now requires confirmatory trials to be well underway, if not fully enrolled, by the time an accelerated approval is granted.

Will biotechs rise to the challenge, or will new FDA demands favor big pharma?

There is now FDA pressure to quickly initiate large, expensive, confirmatory trials. Compared to big pharma, biotechs may not have marketed products to generate revenue. Investment may be dependent on inflection points, such as regulatory filings and approvals. When cash is often limited, will biotechs be able to easily meet these requirements?

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