On August 11th, 2022, the Food and Drug Administration (FDA) approved Enhertu (fam- trastuzumab deruxtecan-nxki) for treatment of advanced non-small cell lung cancer (NSCLC) with an activating HER2 mutation for patients who have received one prior line of therapy. The FDA based their approval on the results of the clinical trial DESTINY-Lung02 which showed that patients who received Enhertu as part of the trial showed a response to the treatment with measurable duration.
Enhertu is the first drug approved by the FDA to treat NSCLC with the HER2 mutation giving patients access to a targeted therapy that they would otherwise not be able to receive. In addition to the approval for this novel treatment, the FDA has approved the next generation sequencing technologies, Oncomine Dx and Guardant360 CDx, as the official companion diagnostics for Enhertu.
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[…] drug targeting a new mutation is Enhertu (fam-trastuzumab deruxtecan-nxki). Enhertu is the first approved drug for the treatment of advanced […]