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Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA. But unlike ORR, PFS is considered by FDA to be a more appropriate measure of stable disease and is thought to be correlated to overall survival.

FDA 40
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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. after ischemic heart disease and stroke. See AgencyIQs analysis of a workshop on novel methodology qualification.] were from cancer.