Precision Medicine in Oncology®

The FDA has issued two draft guidances that will provide regulatory oversight for the use of next-generation sequencing-based tests.

Allison W. Kurian, MD, MSc, associate professor of Medicine and of Health Research and Policy, Stanford University School of Medicine, discusses an ongoing trial exploring the association of ovarian cancer risk with mutations detected by multiple-gene germline sequencing in 95,561 women.

Daniel Sargent, PhD, professor of Oncology and Biostatistics, Mayo Clinic in Rochester, Minnesota, discusses the IDEA initiative, which is an international study to examine if patients with colon cancer would benefit from reducing the duration of adjuvant therapy from 3 months to 6 months to reduce side effects and cost.

Young black women with breast cancer are much less likely to have BRCA testing or, if they carry a BRCA mutation, to undergo risk-reducing prophylactic mastectomy or salpingo-oophorectomy.

John D. Hainsworth, MD, co-founder; principal investigator, Sarah Cannon Research Institute, discusses the results of the MyPathway trial, which was an open-label, phase IIa umbrella basket study.

Treating patients based on the presence of molecular abnormalities regardless of tumor type proved to be a promising strategy in an ongoing phase IIa umbrella basket study.

The FDA has approved new diagnostic tests for the detection of somatostatin receptor-positive neuroendocrine tumors and for EGFR mutations from blood samples for patients with non–small cell lung cancer.