The FDA granted a new indication for trastuzumab deruxtecan-nxki (Enhertu, AstraZeneca/Daiichi Sankyo) to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and who have received prior systemic therapy.
The agency also cleared a companion diagnostic test, Oncomine Dx Target Test (Thermo Fisher Scientific), to identify NCSLC patients who may be candidates for trastuzumab deruxtecan-nxki.
The FDA’s