Approval based on a surrogate endpoint?

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Approval based on a surrogate endpoint?

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" Surrogate - Approval based on a surrogate endpoint or on an effect on a

clinical endpoint other than survival or irreversible morbidity.

FDA may grant marketing approval for a new drug product on the basis of

adequate and well-controlled clinical trials establishing that the drug

product has an effect on a surrogate endpoint that is reasonably likely,

based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to

predict clinical benefit or on the basis of an effect on a clinical endpoint

other than survival or irreversible morbidity.

Approval under this section will be subject to the requirement that the

applicant study the drug further, to verify and describe its clinical

benefit, where there is uncertainty as to the relation of the surrogate

endpoint to clinical benefit, or of the observed clinical benefit to

ultimate outcome.

Postmarketing studies would usually be studies already underway. When

required to be conducted, such studies must also be adequate and

well-controlled.

The applicant shall carry out any such studies with due diligence. "

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandA

pproved/DrugandBiologicApprovalReports/ucm121606.htm

Comment ... experts have noted that it was the validation of Viral Load

surrogate (a blood test) as predictive of clinical benefit that led the

rapid progress against HIV. In contrast, for lymphoma it can take many years

to see if there's a meaningful difference in progression free survival (and

no significant offsetting toxicities) to determine if a new therapy provides

meaningful clinical benefit.

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All the best, ~ Karl

Caregiver to spouse - 14 yr survivor of FL; President, Patients Against

Lymphoma: www.Lymphomation.org

http://forums.lymphoma.com/images/misc/progress.gif