Datroway® has received approval in the European Union (EU) as a metastatic TNBC treatment option. The medicine is approved for adults with unresectable or metastatic triple negative breast cancer (TNBC). It is intended for patients who are not candidates for PD-1/PD-L1 inhibitor therapy.
Daiichi Sankyo and AstraZeneca jointly developed the innovative TROP2 directed ADC using advanced DXd technology. The approval increases the range of therapeutic options for this kind of breast cancer that represents such a serious challenge for patients. The European Commission approved it following a positive opinion from the Committee for Medicinal Products for Human Use. The approval supports its use in eligible patients.
“For people living with metastatic triple negative breast cancer, every new treatment option matters. Despite recent advances, more than two thirds of patients are not candidates for immunotherapy and have had limited options beyond chemotherapy,” said Giuseppe Curigliano, MD, PhD, Director of the Early Drug Development Division, European Institute of Oncology, Professor of Medical Oncology, University of Milan, Italy and investigator for the TROPION-Breast02 trial. “In my practice, I see firsthand the devastating impact this aggressive disease has on patients and their families. This approval of datopotamab deruxtecan provides a new treatment option for eligible patients and represents meaningful progress.”
Datroway Shows Improved Clinical Outcomes in TROPION-Breast02 Trial
In the TROPION-Breast02 study, Datroway demonstrated significant gains in terms of overall survival and progression-free survival. In the TROPION-Breast02 trial, participants were those suffering from metastatic TNBC who had an early recurrence following earlier treatments. The test results showed that Datroway improved median overall survival by five months. It performed better than chemotherapy in the trial.
“With this approval, Datroway is the only TROP2 directed antibody drug conjugate approved in the EU that has demonstrated an overall survival benefit in the first-line setting, representing a meaningful advance for the treatment of patients with metastatic triple negative breast cancer,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “We look forward to bringing Datroway to patients in the EU as an additional treatment option with the potential to extend survival, reflecting our commitment to advancing innovative medicines that address unmet needs for people living with cancer.”
Moreover, the treatment lowers the chance of disease progression or even death by 43%. This drug shows higher response rates than chemotherapy. Objective response rate was 62.5% for the TROP2 directed medicine versus 29.3% for chemotherapy. In conclusion, Datroway contributes to the future treatment of metastatic TNBC in Europe. This is an innovative treatment option for patients who do not have many other options. Besides, this drug signifies further advancement in targeted cancer treatments.
“Every year, more than 80,000 people in Europe are diagnosed with triple negative breast cancer, a disease that often affects younger women and has limited treatment options in the metastatic setting,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “Today’s approval of Datroway brings an antibody drug conjugate with a differentiated clinical profile underpinned by a strong survival benefit to people with this aggressive disease.”
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News Source: Businesswire.com
