FDA Approves AstraZeneca's Datroway for Pretreated Breast Cancer Patients
Tuesday, Jan 21, 2025 1:04 pm ET
2min read The U.S. Food and Drug Administration (FDA) has approved AstraZeneca's Datroway (datopotamab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy. This approval marks a significant milestone in the fight against breast cancer, offering a new treatment option for patients with limited alternatives.
Datroway is a specifically engineered TROP2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The approval was based on the results of the TROPION-Breast01 phase 3 trial, which demonstrated a 37% reduction in the risk of disease progression or death compared to investigator's choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR).
The median progression-free survival (PFS) was 6.9 months in patients treated with Datroway versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the Datroway arm compared to an ORR of 23% observed in the chemotherapy arm. The safety profile of Datroway was consistent with the known profile of this medicine, with no new safety concerns identified. In the Datroway arm, the interstitial lung disease (ILD) rate was 4.2%, and the majority of events were low grade.
"This approval is a major therapeutic milestone for patients with metastatic breast cancer, providing a new treatment alternative to conventional chemotherapy," said Aditya Bardia, MD, MPH, Program Director of Breast Oncology and Director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center and Global Principal Investigator for TROPION-Breast01. "Despite considerable progress in the HR-positive, HER2-negative metastatic breast cancer treatment landscape, new therapies are still needed to tackle the frequent and complex challenge of disease progression after endocrine and initial chemotherapy."
The approval of Datroway has significant potential long-term financial implications for AstraZeneca and Daiichi Sankyo. The drug's efficacy, safety profile, and market size present a substantial opportunity for the companies. Datroway is approved for treating HR-positive, HER2-negative metastatic breast cancer, which accounts for approximately 70% of diagnosed cases in the US, with over 300,000 cases annually. This large market size, coupled with the unmet need for effective therapies after endocrine therapy and initial chemotherapy, presents a substantial opportunity for Datroway.
In conclusion, the FDA's approval of AstraZeneca's Datroway for pretreated breast cancer patients is a significant milestone in the fight against breast cancer. The drug's efficacy, safety profile, and market size present a substantial opportunity for AstraZeneca and Daiichi Sankyo. As the companies continue to develop and commercialize Datroway, they may see significant financial benefits from this innovative cancer treatment.
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