Noted This Week

Daiichi Sankyo announced that the FDA granted accelerated approval to trastuzumab deruxtecan (Enhertu) to treat adults with inoperable or metastatic non–small cell lung cancer (NSCLC) whose tumors have HER2 mutations and who have already received a systemic therapy. The decision was based on the DESTINY-Lung02 trial, in which the confirmed overall response rate (ORR) was 58% and the median duration of response (DOR) was 8.7 months among 52 patients. The agency also approved Life Technologies' Oncomine Dx Target Test and Guardant Health's Guardant360 CDx as companion diagnostics.

More Noted This Week, August 5–11   »