Posted by Michael Wonder on 05 Apr 2024
FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2 positive solid tumours
5 April 2024 - Today, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with unresectable or metastatic HER2 positive (IHC3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options.
Efficacy was evaluated in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumours who were enrolled in one of three multi-centre trials: DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02.
