17 January 2025 – The U.S. Food and Drug Administration (FDA) has granted approval to datopotamab deruxtecan—marketed as Datroway—for the treatment of unresectable or metastatic, HR-positive, HER2-negative breast cancer in patients who have previously undergone therapy. This marks a significant addition to the therapeutic arsenal for a subtype of breast cancer that accounts for a substantial portion of diagnoses and often faces resistance to existing treatments.

Breakthrough Therapy and Expedited Review

The approval comes on the heels of a Breakthrough Therapy designation granted in December 2024, underscoring the agent’s potential to address critical unmet medical needs in oncology.

Clinical Rationale and Impact

Datroway is an antibody–drug conjugate (ADC) that targets Trop‑2—a cell surface antigen prevalent in breast tumors. By combining a robust antibody with a potent cytotoxic payload (deruxtecan), the therapy selectively delivers targeted cell death to cancer cells while sparing healthy tissue. For patients with HR‑positive, HER2‑negative metastatic disease—particularly those who have exhausted endocrine therapies—this approval offers a new option that blends precision targeting with chemotherapy-like potency.

Broader Industry Significance

This approval illustrates several pivotal trends in oncology drug development:

• Expansion of ADCs: The success of ADCs like Datroway—rooted in antigen-targeted mechanisms—continues to reinforce their role as frontline options in resistant cancers.
• Regulatory Agility: The use of Breakthrough Therapy designations signals the FDA’s flexibility in streamlining access to high-potential therapies.
• Treatment Landscape Evolution: Patients with HR-positive, HER2-negative metastatic breast cancer often encounter limited options after hormonal and CDK4/6 inhibitor failures. Datroway’s entry fills this gap, potentially setting new standards for care.

Next Steps for Datroway

With approval in hand, Daiichi Sankyo is expected to prepare for commercialization and may explore confirmatory or expansion trials to further delineate Datroway’s efficacy across other subsets of breast cancer or earlier treatment lines. Additionally, regulators in other jurisdictions—like the EMA—had already issued a positive opinion earlier, positioning the drug for broader global adoption.