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Datroway’s Approval in Breast Cancer Solidifies Daiichi Sankyo’s Leadership in ADCs

Datroway’s Approval in Breast Cancer Solidifies Daiichi Sankyo’s Leadership in ADCs

Datroway demonstrated a 37% reduction in the risk of disease progression compared to chemotherapy, with a median progression-free survival of 6.9 months.

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. The approval makes Datroway AstraZeneca’s eighth new medicine since 2020, the first US approval for Daiichi Sankyo and AstraZeneca’s TROP2-directed ADC and the second based on their proprietary DXd technology.

The FDA approval sent Daiichi Sankyo’s shares soaring by 8.7% to 4,437 yen, reflecting investor confidence. Analysts noted the decision exceeded market expectations, further elevating Datroway’s global profile after its approval in Japan in December.

Datroway leverages DXd technology to precisely target cancer cells. By combining a monoclonal antibody against TROP2 — a protein frequently overexpressed in cancers — with a potent chemotherapy payload, it minimizes damage to healthy cells while attacking tumors effectively.

The approval was based on the TROPION-Breast01 trial, which enrolled 732 patients with advanced disease. The trial’s primary goal was to measure progression-free survival (PFS), the time patients lived without disease worsening.

While overall survival (OS) showed no significant difference, Datroway’s ability to reduce disease progression by 37% compared to chemotherapy was significant. Patients receiving Datroway achieved a median PFS of 6.9 months versus 4.9 months for chemotherapy. Additionally, Datroway showed a 36% objective response rate (ORR), including two complete responses, compared to 23% in the chemotherapy arm.

While the primary efficacy endpoint was PFS, OS was also assessed, with median survival at 18.6 months for Datroway and 18.3 months for chemotherapy. Although the difference in OS was not statistically significant, it highlights the trial’s comprehensive approach to evaluating long-term benefits.


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Beyond its clinical efficacy, Datroway’s ease of administration could further enhance its impact. Administered intravenously every 21 days, the recommended dose is 6 mg/kg (up to 540 mg for patients weighing 90 kg or more). This schedule continues until disease progression or unacceptable toxicity.

The safety profile, assessed in over 360 patients, showed common side effects like fatigue, nausea and stomatitis, with less frequent serious reactions such as interstitial lung disease and ocular issues.

Datroway will be available in the US within two weeks, supported by patient access programs. This approval reinforces Daiichi Sankyo’s strategy to advance ADCs.

Just days before the FDA decision, the company acquired intellectual property rights for gatipotuzumab, a TA-MUC1 antibody underpinning DS-3939, currently in Phase I/II trials for advanced solid tumors.

With over 20 clinical trials targeting cancers such as lung and triple-negative breast cancers, Daiichi Sankyo’s ADC portfolio continues to drive innovation in oncology.