The first HER2+ NSCLC drug was born!

On August 11, the FDA granted accelerated approval for a new indication of Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki, DS-8201) for unresectable or metastatic HER2 mutation-positive adult non-small cell lung cancer who have previously received systemic therapy (NSCLC) patients

The FDA also approved Life Technologies' Oncomine™ Dx (tissue) kit and Guardant Health's Guardant360® CDx (plasma) kit as companion diagnostic tools for Enhertu

The FDA approval is based primarily on results from the multicenter, randomized, double-blind, dose-optimized DESTINY-Lung02 study

The median age of the 52 patients evaluated for efficacy was 58 years (30-78 years), and 69% were female; 79% were Asian, 12% were white, and 10% were other races

In terms of safety, the most common (≥20%) adverse reactions included abnormal laboratory parameters, nausea, decreased white blood cell count, decreased hemoglobin, decreased neutrophil count, decreased lymphocyte count, decreased platelet count, decreased albumin, Increased aspartate aminotransferase, increased alanine aminotransferase, fatigue, constipation, decreased appetite, vomiting, increased alkaline phosphatase, hair loss

On August 5, the FDA just approved Enhertu 4 months ahead of schedule through Real Time Oncology Review (RTOR) and Project Orbis for the treatment of unresectable or metastatic HER2-low (HER2-low) breast cancer patients