Surrogate Endpoints Table: FDA Seeks Feedback

Regulatory NewsRegulatory News | 29 October 2018 |  By 

The US Food and Drug Administration (FDA) on Monday sought feedback on a table of surrogate endpoints that the agency is developing.

The list, which was created thanks to the 21st Century Cures Act and first published last July, includes surrogate endpoints that sponsors have used as primary efficacy clinical trial endpoints for approval of new drug applications (NDAs) or biologics license applications (BLAs). It also includes surrogate endpoints that may be appropriate for use as primary efficacy clinical trial endpoints for drug or biologic approvals, although they have not yet been used to support an approved NDA or BLA.

The list, which will be updated every six months, features surrogate endpoints for numerous diseases including acromegaly, different cancers, chronic kidney disease, cystic fibrosis, hepatitis A, B and C, HIV, hypertension and osteoporosis, among others.

“The acceptability of these surrogate endpoints for use in a particular drug or biologic development program will be determined on a case-by-case basis,” FDA said.

Vinay Prasad, associate professor of medicine at Oregon Health and Science University, previously told Focus: "I would say, at least for cancer, it is done at such a high level with so little detail, it is pretty much useless. A better summary of surrogates used to justify approvals and their strength can be found in our paper from the Mayo Clinic proceedings...We are showing the surrogate used by approval, the pathway of approval, and the strength of the surrogate in the biomedical literature. They just say what surrogates are used in what tumors, but do not explain the line of therapy, the drugs that utilized the pathway or the strength of correlation."


Specifically, FDA welcomes comments concerning: (1) the utility of the surrogate endpoint table; (2) suggestions on surrogate endpoints that may not be reflected on the current table but that have been used for drug or biologic approvals; (3) the best approach for developing future iterations of the table, and (4) surrogate endpoint table questions FDA could address in future communications.

The agency said it will consider comments submitted to the docket as it revises the surrogate endpoint table.

Federal Register


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