Daiichi Sankyo Enhertu Approved for Lung Cancer

FDA has granted Daiichi Sankyo accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating human epidermal growth factor receptor 2 HER2 mutations (as detected by an FDA-approved test). The agency also approved Life Technologies’ Oncomine Dx Target Test (tissue) and Guardant Health’s Guardant360 CDx (plasma) as companion diagnostics for Enhertu. “If no mutation is detected in a plasma specimen, the tumor tissue should be tested,” the agency says.

Approval was based on data from the DESTINY-Lung02 clinical trial involving 52 patients. The major efficacy outcome measures were confirmed objective response rate (ORR) and duration of response (DOR), according to FDA. The confirmed ORR was 58% and the median DOR was 8.7 months, it says.