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FDA Who?


Despite a recent ruling by an FDA panel — which voted to revoke the agency's earlier approval of the use of cancer drug Avastin to treat breast cancer — the National Comprehensive Cancer Network has voted in favor of maintaining its recommendation that Avastin be used for breast cancer, reports Pharmalot's Ed Silverman. Avastin is still approved by FDA for the treatment of other cancers, but the agency — after a series of hearings on the topic — ultimately voted to keep breast cancer off the list of approved indications, citing recent research that suggests Avastin doesn't do enough to help breast cancer patients while exposing them to toxic effects. The move has been somewhat controversial, however, with some groups continuing their support for Avastin to be used in breast Cancer. The Centers for Medicare and Medicaid Services has indicated that it will continue to cover patients using Avastin to treat their breast cancer. And now, the NCCN, a nonprofit group of oncologists has voted — 24 in favor, none against, and one abstention — to continue recommending Avastin, Silverman says. "The endorsement by the NCCN is important because, as a practical matter, this means oncologists will likely continue to use Avastin even if FDA commish Margaret Hamburg decides to rescind the breast cancer indication," he adds. "That would mean Avastin treatment for breast cancer would be relegated to off-label use, forcing third-party payers to decide whether to provide coverage."

The Scan

Study Tracks Responses in Patients Pursuing Polygenic Risk Score Profiling

Using interviews, researchers in the European Journal of Human Genetics qualitatively assess individuals' motivations for, and experiences with, direct-to-consumer polygenic risk score testing.

EHR Quality Improvement Study Detects Demographic-Related Deficiencies in Cancer Family History Data

In a retrospective analysis in JAMA Network Open, researchers find that sex, ethnicity, language, and other features coincide with the quality of cancer family history information in a patient's record.

Inflammatory Bowel Disease Linked to Gut Microbiome Community Structure Gradient in Meta-Analysis

Bringing together data from prior studies, researchers in Genome Biology track down microbial taxa and a population structure gradient with ties to ulcerative colitis or Crohn's disease.

Ancient Greek Army Ancestry Highlights Mercenary Role in Historical Migrations

By profiling genomic patterns in 5th century samples from in and around Himera, researchers saw diverse ancestry in Greek army representatives in the region, as they report in PNAS.