The FDA granted tumor-agnostic accelerated approval to trastuzumab deruxtecan (Enhertu) for previously treated unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid cancers.

All positive (IHC 3+) and doubtful (IHC 2+) cases were screened by fl uorescence in situ hybridization (FISH). Patients with HER2 gene amplification, normal left ventricular ejection fraction ...

The DESTINY-Lung01 trial enrolled HER2-positive (IHC 3+) non-small cell lung cancer patients and reported a confirmed ORR of 52.9%. The DESTINY-CRC02 trial, which included patients with colorectal ...

unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of ...