FDA Approves AstraZeneca, Daiichi Sankyo’s Datroway for Previously Untreated Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer

Image Credit: Adobe Stock Images/Rawpixel.com

The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan or Dato-DXd) for adult patients with previously treated, unresectable, or metastatic HR-positive, HER2-negative breast cancer. According to the company, approval was based on results from the TROPION-Breast01 Phase III trial, which demonstrated a notable reduction in the risk of disease progression or death compared to chemotherapy (hazard ratio 0.63; p<0.0001).¹

“Despite considerable progress in the HR-positive, HER2-negative metastatic breast cancer treatment landscape, new therapies are still needed to tackle the frequent and complex challenge of disease progression after endocrine and initial chemotherapy. The approval of datopotamab deruxtecan, a novel TROP2-directed antibody drug conjugate, marks a major therapeutic milestone and provides patients with metastatic breast cancer a new treatment alternative to conventional chemotherapy,” global principal investigator for TROPION-Breast01, Aditya Bardia, MD, MPH, program director, breast oncology, director, translational research integration, UCLA Health Jonsson Comprehensive Cancer Center, said in a press release.

The global, randomized, multicenter, open-label TROPION-Breast01 trial evaluated the efficacy and safety of intravenous Datroway (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy. Consisting of 732 patients across Africa, Asia, Europe, North America and South America, the dual primary endpoints of the study were progression-free survival (PFS) and overall survival (OS). Key secondary endpoints included overall response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy, and safety.

Results found that Datroway demonstrated a 37% reduction in the risk of disease progression or death. Additionally, median PFS was 6.9 months with Datroway compared to 4.9 months with chemotherapy. Further, the treatment’s safety profile was found to be consistent with its known profile and no new safety signals were reported.¹

“With this first approval of Datroway in the US, we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers. We are proud to bring Datroway to people living with metastatic HR-positive, HER2-negative breast cancer, and this approval marks the eighth new medicine of the 20 we have set out to deliver across AstraZeneca by 2030,” said Dave Fredrickson, EVP, oncology hematology business unit, AstraZeneca, in the press release.

According to the American Cancer Society, breast cancer is the most common cancer in women in the United States, other than skin cancers. It accounts for approximately 30% of all new cancers in females annually. In 2024, it was estimated that there were 310,720 new cases of invasive breast cancer and 42,250 deaths. It is most common in older and middle-aged women, with a median diagnosis age of 62 years; however, a small number of women develop the disease at an age younger than 45 years.

It is estimated that women face a 13% chance of developing breast cancer. The incidence rate is increasing by 0.6% annually, with a 1% rise in women under 50 years of age.²

“The approval of Datroway provides patients with HR-positive, HER2-negative breast cancer previously treated with endocrine-based therapy and traditional chemotherapy with the opportunity to be treated with a new TROP2-directed antibody drug conjugate earlier in the metastatic setting. Datroway is the latest addition to our portfolio of innovative cancer treatments and marks the fourth medicine from our oncology pipeline to receive approval in the US,” said Ken Keller, global head, oncology business, president, CEO, Daiichi Sankyo, in the press release.

References

1. Datroway (datopotamab deruxtecan) approved in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer. AstraZeneca. January 17, 2025. Accessed January 20, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/dato-dxd-approved-in-us-for-hr-p-breast-cancer.html

2. Key Statistics for Breast Cancer. American Cancer Society. Accessed January 20, 2025. https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html