AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has secured approval in the European Union as a new first-line treatment option for adults with metastatic triple-negative breast cancer (TNBC).

 

The approval makes Datroway the only TROP2-directed antibody drug conjugate approved in the EU to demonstrate an overall survival benefit in the first-line treatment of metastatic TNBC — a disease with some of the most limited treatment options in oncology.

 

The European Commission’s decision follows a positive recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the Phase III TROPION-Breast02 trial, which demonstrated statistically significant and clinically meaningful improvements in both overall survival and progression-free survival compared with chemotherapy.

 

Giuseppe Curigliano, investigator for the TROPION-Breast02 trial, said: “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. 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.”

 

The trial showed Datroway delivered a median overall survival of 23.7 months compared with 18.7 months for chemotherapy — an improvement of five months — while reducing the risk of disease progression or death by 43%.

 

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “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. 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.”

 

Datroway also produced stronger treatment responses, achieving an objective response rate of 62.5% compared with 29.3% for chemotherapy.

 

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc, said: “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 1st-line setting for the treatment of patients with metastatic triple-negative breast cancer. 

 

"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.”

 

The TROPION-Breast02 trial enrolled 644 patients across Africa, Asia, Europe, North America and South America. The global Phase III study compared Datroway with investigator-selected chemotherapy in previously untreated patients with locally recurrent inoperable or metastatic TNBC who could not receive immunotherapy.

 

The companies are continuing a broad clinical development programme for Datroway, with more than 20 trials underway across breast cancer, lung cancer and other tumour types.

 

AstraZeneca said the approval reinforces its commitment to advancing new cancer treatments and transforming outcomes for patients with difficult-to-treat cancers.