On June 24, 2021, the U.S. Food and Drug Administration (FDA) issued drafted guidance that encourages the inclusion the patients with incurable cancers in clinical trials, regardless of their treatment history. When finalized, the FDA's guidance will "provide recommendations to sponsors designing clinical trials of drug and biological products to expand eligibility to patients with incurable cancers."
It will also provide guidance on how to address patients who have not received prior therapies, such as using separate cohorts.
Read the full FDA draft guidance for sponsors.
Posted 6/25/2021
In recognition of Leukemia and Lymphoma Awareness Month, ACCC compiled a group of resources to help care teams navigate two of the most commonly diagnosed adult leukemias: acute myeloid leukemia and chronic lymphocytic leukemia.
