The biologics license application from the FDA is supported by data from the phase 3 TROPION-Breast01 trial of datopotamab deruxtecan in HR-positive, HER2-negative breast cancer.
The FDA accepted the BLA of Dato-DXd, a TROP2-directed antibody-drug conjugate, in patients with HR+, HER2– breast cancer that has been previously treated with systemic therapy. A PDUFA target action date has been set for the first quarter of 2025.1
The BLA is supported by findings from the phase 3 TROPION-Breast01 trial (NCT05104866). According to data presented at the 2023 European Society of Medical Oncology Annual Congress, Dato-DXd reduced the risk of disease progression or death by 37% compared with investigator’s choice of chemotherapy (HR, 0.63; 95% CI, 0.52-0.76; P <.001) as assessed by blinded independent central review. The confirmed objective response rates (ORR) were 36.4% and 22.9% for Dato-DXd and chemotherapy, respectively.2
Progression-free survival (PFS) findings were presented at the 2023 San Antonio Breast Cancer Symposium. A median PFS of 6.9 months was observed in patients treated with Dato-DXd (n = 365) vs 4.9 months in patients who received chemotherapy (n = 367; HR, 0.63; 95% CI, 0.52-0.76; P <.0001).3
“Despite marked progress in the treatment of HR-positive, HER2-negative breast cancer, most patients with advanced disease develop endocrine resistance and face the prospect of one or several lines of chemotherapy. If approved, datopotamab deruxtecan has the potential to provide these patients an efficacious and better tolerated alternative to conventional chemotherapy,” said Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, in a press release.1
In February 2024, the FDA accepted a BLA for Dato-DXd for the treatment of nonsquamous NSCLC, and a PDUFA target action date is anticipated in the fourth quarter of 2024.4
TROPION-Breast01 is a phase 3, open-label, randomized study of Dato-DXd vs investigator’s choice of chemotherapy in patients with inoperable or metastatic HR+, HER2– breast cancer who have received 1 or 2 prior lines of systemic therapy. The study has an enrollment of 732 patients across sites in 10 states in the US and 19 additional countries.5
The study’s primary end points are PFS and overall survival, and secondary end points include ORR, duration of response, PFS by investigator assessment, disease control rate, time to first subsequent therapy, and time to second subsequent therapy.
The study is active but not recruiting and has an estimated completion date of August 15, 2025.
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