FDA Approves Innovative ADC Datroway for Metastatic HR+, HER2- Breast Cancer

The FDA has approved Datroway® (datopotamab deruxtecan-dlnk) for adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer. This innovative TROP2-directed antibody-drug conjugate (ADC) provides a much-needed treatment option for patients previously treated with endocrine-based therapy and chemotherapy.

The TROPION-Breast01 Trail

The approval is based on results from the TROPION-Breast01 Phase III trial, which demonstrated a 37% reduction in the risk of disease progression or death compared to chemotherapy (hazard ratio 0.63; 95% CI 0.52–0.76). Median progression-free survival was 6.9 months with Datroway compared to 4.9 months for chemotherapy, underscoring its potential to significantly improve outcomes for patients.

Randomization was stratified by previous lines of chemotherapy, prior CDK4/6 inhibitor treatment, and geographical region. A total of 732 patients were randomized (1:1) to datopotamab deruxtecan-dlnk (n=365) or investigator’s choice of chemotherapy (n=367); eribulin (60%), capecitabine (21%), vinorelbine (10%), or gemcitabine (9%).

Dr. Aditya Bardia, a key figure in breast oncology at UCLA Health, emphasized the importance of this achievement: “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.”

Redefining Cancer Treatment with ADC

Datroway is a TROP2-directed antibody drug conjugate (ADC), a class of targeted therapies that combines an antibody with a cytotoxic drug. The therapy specifically delivers its potent payload to cancer cells expressing the TROP2 protein, minimizing damage to healthy tissues.

Dave Fredrickson, EVP, Oncology Hematology Business Unit, AstraZeneca, said: “With this first approval of Datroway in the US, we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers.”

A Closer Look at Safety

The safety profile of Datroway aligns with expectations, with no new safety concerns identified during trials. The most common adverse reactions (≥20%), including laboratory abnormalities, were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST, and increased alkaline phosphatase.

Ken Keller, President and CEO, Daiichi Sankyo, said: “The approval of DATROWAY is the latest addition to our portfolio of innovative cancer treatments and marks the fourth medicine from our oncology pipeline to receive approval in the US.”

A New Option for an Urgent Need

Caitlin Lewis from Living Beyond Breast Cancer highlighted the significance of the approval:  “Only one in three patients with metastatic HR-positive, HER2-negative breast cancer live more than five years following diagnosis, highlighting the urgent need for additional effective therapies. The approval of Datroway is a significant advance, offering patients with metastatic HR-positive breast cancer a new and much-needed treatment option.”

In addition to the US, regulatory submissions for Datrowayare under review in the EU, China, and other regions, aiming to bring this promising therapy to patients globally.