The US Food and Drug Administration approved DATROWAY for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC). This regulatory milestone addresses individuals who are not eligible candidates for PD-1/PD-L1 inhibitor therapies. The clinical decision follows a designated Priority Review process. AstraZeneca and Daiichi Sankyo jointly develop and commercialize this new therapeutic option.
The product represents a specifically engineered TROP2-directed DXd antibody drug conjugate. Clinical data derived from the TROPION-Breast02 Phase III trial supported the submission. This specific trial evaluated patients needing first-line medical intervention.
MD, FASCO, Section Head, Triple-Negative Breast Cancer Clinical Research Program, Memorial Sloan Kettering Cancer Center, and investigator for TROPION-Breast02, Tiffany A. Traina, MD, FASCO, discussed the survival outcomes.
“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.”
Executive Director, Triple Negative Breast Cancer Foundation, Arlene Brothers, explained what this milestone means for individuals facing limited choices.
“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.”
Clinical Efficacy Results
Furthermore, the data showed a statistically significant 5.0-month improvement in median overall survival compared to traditional chemotherapy. The therapy achieved an objective response rate of 64 percent. Chemotherapy generated a 30 percent response rate.
Additionally, the treatment demonstrated a 43 percent reduction in the risk of disease progression or death. The documented safety profile remained entirely consistent with previous clinical trials.
Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, Dave Fredrickson, highlighted the manufacturing corporate goals.
“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.”
Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., Ken Keller, outlined the broader potential impact across the medical sector.
“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.”
The NCCN Guidelines now include the treatment as a Category 1 Preferred option. International partners are also reviewing the therapy through Project Orbis. Active reviews continue inside Australia, Canada, Singapore, Switzerland, the EU, China, and Japan.
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News Source: Businesswire.com
