Daiichi Sankyo and AstraZeneca’s TROP2-ADC DATROWAY Receives EU Approval for HR+/HER2- Metastatic Breast Cancer

April 8, 2025Daiichi Sankyo announced that DATROWAY (datopotamab deruxtecan) has been approved by the European Union (EU) for patients with previously treated hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.The approval is based onTROPION-Breast01The3Results of the phase trial.

Research shows that, compared with standard chemotherapy,DATROWAYReduced the risk of disease progression or death37%。DATROWAYThe median progression-free survival period is6.9Months, chemotherapy is4.9Months.DATROWAYThe objective response rate was36%, The objective response rate of chemotherapy is23%,The median duration of response was6.7Months and5.7Months.

The overall survival results were not statistically significant.DATROWAYMedianOSFor18.6Months, chemotherapy for18.3Months. The most common3Grade or higher adverse events include stomatitis (7.9%), fatigue (4.3%) and anemia (3.2%）。

AstraZeneca in the EUDATROWAYThe approval solidified its growing oncology franchise and advanced its strategic partnership with Daiichi Sankyo. FollowingEnhertuFollowing approval in Europe, this is the second one they have co-developed.ADCApproved in Europe, also Daiichi-SankyoDXdThe platform's third approval.

The commercial opportunity is significant, with the goal being the majority of breast cancer cases.HR+/HER2-Segmented market.DATROWAYProvides an effective option for patients who progress after endocrine therapy and initial chemotherapy, involving a large patient population.

However, the lack of overall survival benefits in key trials may limit market adoption, potentially affecting reimbursement negotiations and physician uptake, especially in cost-sensitive markets like Europe. WithoutOSIn the case of advantages, superior progression-free survival and response rates provide a compelling value proposition, but payers will scrutinize cost-effectiveness.

Strategically, this approval further validates AstraZeneca'sADCSignificant investments in technology and oncology, while expanding its breast cancer portfolio toEnhertuBeyond.DATROWAYContributed to AstraZeneca's diversification in the field of oncology and demonstrated its continued execution in the product pipeline. The company's influence in the precision oncology field continues to expand. Notably, its competitor Pfizer/SeagenAnd Gilead/Immunomedicsetc., are also under development targetingTROP2Therapy.

References:

[1]Daiichi-SankyoOfficial Website.

[2]DATROWAY®ApprovedintheEUforPatientswithPreviouslyTreatedMetastaticHRPositive,HER2NegativeBreastCancer.stocktitan.20250408.