3 FDA Guidances Support Cancer Moonshot: Pazdur

FDA has issued three final guidances on cancer clinical trials that agency officials say parallel the goals of President Biden’s effort to renew his 2016 Cancer Moonshot to facilitate continued advancement in cancer prevention, detection, research, and patient care. FDA Oncology Center of Excellence director Richard Pazdur says that through the documents FDA is “recommending important principles that involve addressing inequities, targeting the right treatments to the right patients, speeding progress against the most deadly and rare cancers, and learning from the experience of all patients.” The guidances are: 

•          Inclusion of Older Adults in Cancer Clinical Trials,
•          Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics, and
•          Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.