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July 08, 2021

FDA Recommends Inclusion of Patients with Incurable Cancers in Oncology Trials

On June 25, FDA issued draft guidance that recommends sponsors designing clinical trials of drug and biological products expand eligibility to patients with incurable cancers. FDA is encouraging the industry to include patients with incurable cancers in cancer clinical trials, regardless of whether they have received existing alternative treatment options. FDA also recommends that sponsors evaluate patients who have not received any available therapies in separate cohorts from those who have received available therapies.

The guidance is part of FDA’s broader initiative to encourage expanded patient eligibility for oncology clinical trials. It also responds to clinical eligibility criteria that often prevents patients with incurable cancers from enrolling in clinical trials.