Stakeholders Urge Collaboration to Prove ctDNA as Regulatory Endpoint for Early Cancer Drugs

The precision oncology community is hoping it could soon see a new landscape of drug trials using circulating tumor DNA as an early or surrogate endpoint for adjuvant therapies and other treatments in early-stage disease.

In a recent draft guidance, the US Food and Drug Administration said that while the evidence isn’t there yet to support these types of approvals, it could be soon. Thus, stakeholders are hoping to be proactive in developing the right kind of foundational data.

Source: https://www.genomeweb.com/cancer/stakeholders-urge-collaboration-prove-ctdna-regulatory-endpoint-early-cancer-drugs#.YuqESnbMKUk