FDA approves new lung cancer diagnostic tool, intraveneous opioid

Aug 10, 2020 - 03:00 PM
FDA product update

The Food and Drug Administration Friday approved the first liquid biopsy companion diagnostic that uses next-generation sequencing technology to identify patients with specific gene mutations in a deadly form of metastatic non-small cell lung cancer.

“In addition to benefitting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms,” said Tim Stenzel, M.D., director of FDA’s Office of In Vitro Diagnostics and Radiological Health.

In other news, the agency Friday approved a new intraveneous opioid for managing acute pain in adults in hospital and other controlled clinical settings, such as inpatient and outpatient procedures. The drug, Olinvyk (oliceridine), has a maximum recommended daily dose limit of 27 milligrams.

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