Citations re MRD / CTDNA in Solid Tumors, FDA

 This FDA draft guidance for ctDNA as surrogate outcome in solid cancers appeared in May 2022.

 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-circulating-tumor-deoxyribonucleic-acid-early-stage-solid-tumor-drug-development-draft-guidance

GUIDANCE DOCUMENT

Use of Circulating Tumor Deoxyribonucleic Acid for 

Early-Stage Solid Tumor Drug Development; 

Draft Guidance for Industry; AvailabilityMAY 2022

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It was viewed as "conservative" relative to their prior guidance on ctDNA or MRD as a new surrogate in hematolymphoid cancers. Jan 2020: https://www.fda.gov/media/134605/download  

 

 

Stakeholders have been urging the FDA to move faster.

 

FOCR Webpage for ctDNA (MRD) for treatment response.

https://friendsofcancerresearch.org/ctdna/

 

FOCR White paper roadmap for using ctDNA in regulatory decisions 16pp

https://friendsofcancerresearch.org/wp-content/uploads/Circulating_Tumor_DNA_in_Development_of_Therapies_for_Cancer-Evidentiary_Roadmap.pdf

 

FOCR news article July 2022

https://friendsofcancerresearch.org/news/regulatory-focus-drugmakers-seek-details-on-use-of-ctdna-as-a-biomarker-or-early-endpoint/

 

 

Genomeweb article, COPIED on FOCR website (July 2022)

https://friendsofcancerresearch.org/news/genomeweb-stakeholders-urge-collaboration-to-prove-ctdna-as-regulatory-endpoint-for-early-cancer-drugs/

 

Oncology Times - cheerleader for ctDNA in solid cancers August 2022

https://friendsofcancerresearch.org/news/oncology-times-the-promising-role-of-circulating-tumor-dna-as-a-cancer-biomarker/