A collection of recently published news items.
The FDA finalized two guidances for the development of next-generation sequencing tests. The first guidance outlines how developers can use clinical evidence from FDA-recognized public databases like ClinGen to support the clinical validation of their tests. The second guidance provides recommendations for designing, developing, and validating tests used to diagnose genetic diseases. Both are available at www.fda.gov.
The FDA declined to approve PF-05280014, Pfizer's biosimilar of trastuzumab (Herceptin; Roche), which is used to treat certain forms of breast and gastric cancers. The agency approved trastuzumab-dkst (Ogivri), Mylan's biosimilar of the drug, in December 2017.
The Lustgarten Foundation and Stand Up To Cancer announced that they are partnering to accelerate research to increase survival of patients with pancreatic cancer. The two groups will fund the Pancreatic Cancer Collective with an initial commitment of $25 million.
Cancer researchers published The Pan-Cancer Atlas, a database containing genomic and molecular data on 33 types of cancer from more than 10,000 patients (see https://www.cell.com/pb-assets/consortium/pancanceratlas/pancani3/index.html). So far, 27 papers have been published based on the results.
Updated MOSCATO-01 trial results presented at the American Association for Cancer Research Annual Meeting 2018 indicate tailoring treatment to the genetic makeup of a patient's tumor may not improve overall survival (OS). Patients matched to targeted therapies based on “actionable” genetic mutations did not have significantly better OS than those who were not. Previous findings from the trial indicated that 33% of patients matched to therapies based on genetic alterations experienced an extended progression-free survival of 30% (Cancer Discov 2017;7:586–95).
Higher cigarette prices would cause millions to stop smoking, according to recent research (BMJ 2018;361:k1162). Researchers conducted an analysis of 500 million male smokers in 13 countries and found that a 50% increase in the cost of cigarettes would result in 67 million men quitting the habit, and 449 million years of life gained.
For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/CDNews.