Sara Hurvitz, MD, Discusses the Full Approval of Second-Line T-DXd in HER2+ Breast Cancer

Approval Alert | <b>Trastuzumab Deruxtecan for HER2-positive Breast Cancer</b>

Sara Hurvitz, MD, spoke about to recent approval of fam-trastuzumab deruxtecan-nxki in the second-line setting for patients with HER2-positive breast cancer.

During an interview with CancerNetwork®, Sara Hurvitz, MD, associate professor at the David Geffen School of Medicine, medical director at the Johnson Comprehensive Cancer Center Clinical Research Unit, co-director of the Santa Monica University of California Los Angeles (UCLA) Outpatient Oncology Practices, and director of the Breast Cancer Clinical Trials Program at the UCLA, discussed the approval of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for patients with unresectable or metastatic HER2-positive breast cancer who have received prior anti-HER2-based treatments.1

The approval was based on the results of the phase 3 DESTINY-Breast03 trial (NCT03529110) which assessed the use of T-DXd vs ado-trastuzumab emtansine (T-DM1; Kadcyla).2 A 72% reduction in the risk of disease progression or death was observed in the T-DXd arm compared with the T-DM1 arm (HR, 0.28; 95% CI, 0.22-0.37; P <.0001).


T-DXd has been approved now for a couple of years based on an accelerated approval, so patients have already had access to T-DXd. [However], the full approval for patients in the second-line setting and beyond is a great news for patients. We saw data from the DESTINY-Breast03 clinical trial that indicates T-DXd is better in terms of progression-free survival [PFS] and overall survival [OS] than T-DM1 in patients previously treated with at least 1 prior line of therapy. This now makes this drug technically available to our patients in the second-line setting and later, and the responses that we’re seeing with PFS, which was statistically significantly improved with T-DXd, are quite impressive. There’s a strong trend toward an improvement in OS that hasn’t yet met statistical significance but is very exciting and very encouraging. For patients diagnosed with HER2-positive breast cancer, this is big news.


  1. Enhertu approved in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen. News release. AstraZeneca. May 5, 2022. Accessed May 20, 2022.
  2. Cortés J, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386(12):1143-1154. doi:10.1056/NEJMoa2115022