Trastuzumab Deruxtecan & Non-Small-Cell Lung Carcinoma (NSCLC) (HER2 m)

FDA status:

The U.S. FDA gave accelerated approval on August 11, 2022 for Trastuzumab Deruxtecan. It is for adult patients with unresectable or metastatic Non-Small-Cell Lung Carcinoma (NSCLC) (HER2 m). An FDA‑approved test detects these mutations and patients must have had prior systemic therapy (1, 2, 4).

EMA status:

EMA has not granted a separate indication for Non-Small-Cell Lung Carcinoma (NSCLC) (HER2 m) yet . Enhertu’s EU authorization includes HER2‑positive breast cancer, HER2‑positive gastric cancer, and HER2‑positive solid tumors. ISome European centers may use Trastuzumab Deruxtecan off‑label in HER2‑mutant NSCLC. Th…