The FDA has granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive solid tumors who have undergone prior systemic treatment and have no satisfactory alternative options. Clinical Trial This approval was based on three multicentre clinical trials, namely DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02, which evaluated the efficacy of this drug in 192 adult patients with previously treated unresectable or metastatic HER2-positive solid tumors. The primary efficacy outcome measure across all trials was the confirmed objective response rate (ORR), with an additional measure being the duration of response (DOR).
These outcomes were evaluated by independent central review (ICR) based on RECIST v1.1. In DESTINY-PanTumor02, the ORR was 51.4%, and the median DOR was 19.4 months. In DESTINY-Lung01, the ORR was 52.9%,…
