First FDA Approved Targeted Therapy for HER2, Enhertu, for the Treatment of NSCLC With an Activating HER2 Mutation

[Miranda_GO2]

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.

FDA Press Release: fda.gov/drugs/resources-inf...

[PegD]

I took part in the DESTINYLUNG01 clinical trial which included HER2 overexpression determined by IHC testing which qualified me for the trial (I do not have a HER2 mutation, I have HER4). I was on Enhertu for 18 months. Very exciting results which offers hope for those with HER2.

[Denzie Moderator Volunteer]

This is wonderful.