The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan, a novel antibody-drug conjugate, for the treatment of certain patients with unresectable or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. The approval was based on results from a randomized clinical trial involving 732 patients who had received prior endocrine therapy and chemotherapy.
The trial showed improved response rates and progression-free survival in patients treated with datopotamab deruxtecan compared to those receiving standard chemotherapy. Median progression-free survival was significantly longer at 6.9 months, while median overall survival did not differ between the two groups.
Common adverse reactions reported by patients included laboratory abnormalities, gastrointestinal issues, and fatigue. The recommended dose of datopotamab deruxtecan is 6 mg/kg, administered once every three weeks until disease progression or unacceptable toxicity.
This approval marks the first time an antibody-drug conjugate has been approved in the US for breast cancer treatment. Following FDA approval in Japan last year, Daiichi Sankyo and AstraZeneca are now planning to submit a Biologics License Application for the use of datopotamab deruxtecan in non-small cell lung cancer, with over 20 trials evaluating its efficacy and safety across multiple cancers underway.
Source: https://www.medscape.com/viewarticle/fda-approves-new-adc-hr-her2-breast-cancer-2025a100017n?form=fpf