Based on data from the DESTINY-Breast03 phase 3 trial reported at the European Society for Medical Oncology Congress 2021, the US Food and Drug Administration (FDA) awarded trastuzumab deruxtecan a Breakthrough Therapy Designation (BTD). This is trastuzumab deruxtecan’s second BTD in breast cancer, bringing the total number of BTDs for this drug to 4. The BTD is a program created by the FDA to expedite the development and review of prospective new medications that are intended to treat a serious ailment and fill a major unmet medical need. The new treatment must have shown promising preliminary clinical outcomes that exhibit a significant improvement over existing medicines on a clinically important end point.1
Trastuzumab deruxtecan is an antibody–drug conjugate that targets HER2 that was developed by Daiichi Sankyo (currently co-produced with AstraZeneca). In December 2019, the FDA approved trastuzumab deruxtecan for the treatment of patients with unresectable or metastatic HER2-positive breast cancer following ≥2 lines of anti-HER2 therapy. The median duration of response to trastuzumab deruxtecan in patients with HER2-positive metastatic breast cancer who had previously received trastuzumab emtansine was 14.8 months, and the median duration of progression-free survival was 16.4 months in a phase 2 trial evaluating trastuzumab deruxtecan in patients with HER2-positive metastatic breast cancer who had previously received trastuzumab emtansine.
Based on the results of DESTINY-Gastric01, the FDA approved fam-trastuzumab deruxtecan-nxki in January 2021 for patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer. Fam-trastuzumab deruxtecan was found to be superior to single-agent chemotherapy (irinotecan or paclitaxel) as a third-line (or later) treatment for HER2-positive gastric and gastroesophageal junction adenocarcinoma in this trial, with a median overall survival of 12.5 months in the fam-trastuzumab deruxtecan arm compared with 8.4 months in the chemotherapy arm.2
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