The US Food and Drug Administration has published a final guidance and two draft guidances that detail its thinking on developing certain types of new cancer drugs. The guidances are meant to provide advice to sponsors on developing drugs to treat acute amyloid leukemia (AML), reporting certain clinical trial adverse events and developing tissue-agnostic cancer drugs.
On 17 October, FDA released three guidances, including a final guidance titled Acute Myeloid Leukemia (AML): Developing Drugs and Biological Products for Treatment. The guidance was originally published in draft form two years ago and it broadly outlines the agency’s thinking on AML drug development programs and clinical trial designs to support such products, including indications for individual phase of treatment. (RELATED: Draft AML guidance takes targeted therapies into account, Regulatory Focus 17 August 2020)…
