FDA looks to broaden cancer trial eligibility

In an attempt to accelerate development of cancer therapies for under-represented patient populations, FDA is aiming to expand eligibility criteria to increase enrollment of children, adolescents and other patient groups in trials of cancer drugs. The agency released four draft guidances Tuesday with suggested eligibility criteria for including pediatric patients ages two to less than 12; patients with HIV, HBV or HCV infections; patients with brain metastases; and patients with organ dysfunction or prior or concurrent malignancies.