ENHERTU approved for treatment of unresectable or metastatic HER2 positive

Daiichi Sankyo (DSNKY) and AstraZeneca’s (AZN) ENHERTU has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02, DESTINY-Lung01 or DESTINY-CRC02. The major efficacy outcome measure in all three of the studies was confirmed ORR and an additional efficacy outcome measure was DOR. ENHERTU is approved with Boxed WARNINGS for interstitial lung disease/pneumonitis and Embryo-Fetal toxicity.