DATROWAY® (datopotamab deruxtecan-dlnk) approved in the US as the first TROP2-directed antibody-drug conjugate for first-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
AstraZeneca and Daiichi Sankyo’s DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
The approval follows priority review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.
Tiffany A. Traina, MD, FASCO, Section Head, Triple-Negative Breast Cancer Clinical Research Program, Memorial Sloan Kettering Cancer Center, and investigator for TROPION-Breast02, said, “Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the 1st-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy.” This approval will bring a much-needed treatment option for these patients.”
Arlene Brothers, executive director of the Triple Negative Breast Cancer Foundation, said, “For seven out of 10 patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option. Today’s approval of DATROWAY means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment.”
Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca, said, “Triple-negative breast cancer is notoriously difficult to treat. Patients with metastatic disease, especially those who are unable to receive immunotherapy, urgently need more effective, durable, and tolerable treatment options that extend survival. With today’s approval, we are proud to bring DATROWAY to a broad population of advanced triple-negative breast cancer patients, and we continue to study its promise as a mainstay treatment across tumors, stages, and settings.”
Ken Keller, Global Head of Oncology Business and President and CEO, Daiichi Sankyo, Inc., said, “As the first antibody drug conjugate to demonstrate a median overall survival of two years in the 1st-line metastatic setting of triple-negative breast cancer, DATROWAY has the potential to redefine the treatment landscape for these patients. With this approval, DATROWAY is now approved for three indications in the US, including two for breast cancer, underscoring its potential to play an important role across tumor types.”
In the trial, DATROWAY demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0290) and a 43% reduction in patients’ risk of disease progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this patient population. DATROWAY was also associated with more robust treatment responses, including an objective response rate (ORR) of 64% compared to an ORR of 30% with chemotherapy.1
The safety profile of DATROWAY in TROPION-Breast02 was consistent with previous clinical trials of DATROWAY in breast cancer.
This application was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, reviews are ongoing in Australia, Canada, Singapore, and Switzerland. This initiative is designed to bring effective cancer treatments to patients as early as possible. Additional reviews are underway in the EU, China, and Japan.
Based on the results of TROPION-Breast02, datopotamab deruxtecan (DATROWAY) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a Category 1 Preferred first-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy. See NCCN Guidelines® for detailed recommendations.2
DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR DATROWAY® (datopotamab deruxtecan-dlnk)
Indications
DATROWAY® is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:
- adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
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 the confirmatory trial. - adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
- adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in oncology, rare diseases, and biopharmaceuticals, including cardiovascular, renal & metabolism, and respiratory & immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide.
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