China Approved DATROWAY (Datopotamab Deruxtecan) for HR-Positive, HER2-Negative Metastatic Breast Cancer

On August 25, 2025, China approved DATROWAY (datopotamab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have previously received endocrine therapy and at least one line of chemotherapy in the advanced setting.

This marks the first approval of DATROWAY in China and the second antibody-drug conjugate (ADC) based on Daiichi Sankyo’s proprietary DXd technology to receive approval in the country, following ENHERTU.

Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca, said:

“Despite considerable advancements in the treatment of HR positive breast cancer, new medicines are still needed to tackle the frequent and complex challenge of disease progression following initial therapies. We are proud to bring DATROWAY to patients in China for the first time, offering those with metastatic HR positive, HER2 negative breast cancer a new and needed option.”

LinkedIn photo of Dave Fredrickson

Professor Binghe Xu, Director of Clinical Trial Center (GCP) of National Cancer, Center, Cancer Hospital Chinese Academy of Medical Sciences, and China leading PI of TROPION-Breast01, shared:

“Despite the progress we have made in managing hormone receptor–positive, HER2-negative metastatic breast cancer, many patients still face limited options once their disease progresses after endocrine therapy and chemotherapy. The approval of [Dato-DXd], a novel TROP2-directed antibody-drug conjugate, represents a meaningful step forward in expanding therapeutic choices for patients with breast cancer.”

What research is behind the approval?

The approval is based on the global phase 3 TROPION-Breast01 trial, which is a global Phase 3, randomized, open-label trial comparing Datopotamab deruxtecan-dlnk (6 mg/kg every 21 days) with investigator’s choice of chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who progressed after endocrine therapy and at least one prior line of chemotherapy. Crossover between treatment arms was not allowed, though patients could receive subsequent therapies after progression.

The study’s primary endpoints were:

• Progression-Free Survival (PFS) assessed by blinded independent central review
• Overall Survival (OS)

Key secondary endpoints included objective response rate (ORR), duration of response (DoR), disease control, time to next therapy, and safety.

Results of TROPION-Breast01 Trial

The trial enrolled 732 patients worldwide. Datopotamab deruxtecan-dlnk demonstrated a 37% reduction in risk of disease progression or death versus investigator’s choice chemotherapy (hazard ratio [HR] = 0.63; 95% confidence interval [CI]: 0.52–0.76; p < 0.0001), as assessed by blinded independent central review.

Patients treated with DATROWAY achieved a median progression-free survival (PFS) of 6.9 months (95% CI: 5.7–7.4) compared with 4.9 months (95% CI: 4.2–5.5) for chemotherapy . The confirmed objective response rate (ORR) favored DATROWAY at 36% (95% CI: 31%–42%) versus 23% (95% CI: 19%–28%) in the chemotherapy arm; this included two complete responses (0.5%) and 131 partial responses (36%) with DATROWAY, compared to no complete responses and 84 partial responses (23%) with chemotherapy.

The median duration of response (DoR) was also longer in the DATROWAY arm at 6.7 months (95% CI: 5.6–9.8) versus 5.7 months (95% CI: 4.9–6.8) with chemotherapy.

Although final overall survival (OS) did not show a statistically significant difference (HR = 1.01; 95% CI: 0.83–1.22), an exploratory sensitivity analysis adjusting for subsequent ADC treatment indicated a modest OS improvement: median OS of 19.1 months for DATROWAY versus 17.5 months for chemotherapy (HR = 0.86; 95% CI: 0.70–1.06).

An evaluation of the China subgroup

An evaluation of the China subgroup (83 patients) enrolled in the trial revealed even more pronounced benefits: median PFS of 8.1 months on DATROWAY versus 4.2 months on chemotherapy (HR = 0.54; 95% CI: 0.30–0.96), with ORR of 38.6% versus 17.9%, respectively

Safety and Tolerability

DATROWAY’s safety profile remains consistent with expectations for ADC therapies. In the full TROPION-Breast01 set:
The rate of grade ≥3 treatment-related adverse events (TRAEs) was significantly lower in the DATROWAY arm (20.8%) compared to chemotherapy (44.7%). The most common TRAEs (any grade) included nausea (51.1%), stomatitis (50%), alopecia (36.4%), while chemotherapy was associated more frequently with neutropenia (42.5%).

You can read more about the approval of DATROWAY in China on Daiichi Sankyo‘s official website 

Does DATROWAY Have FDA Approval?

Datopotamab deruxtecan-dlnk is FDA-approved for two advanced cancers. In January 2025, it was approved for adults with HR-positive, HER2-negative unresectable or metastatic breast cancer who had previously received endocrine therapy and chemotherapy, based on improved progression-free survival and response rates versus standard chemotherapy.

In June 2025, it received accelerated approval for adults with EGFR-mutated locally advanced or metastatic NSCLC who had prior EGFR-targeted therapy and platinum-based chemotherapy, supported by durable tumor responses in a population with limited options.

Efficacy of datopotamab deruxtecan-dlnk for breast cancer was evaluated in TROPION-Breast01, a global, multicenter, open-label, randomized phase 3 trial, with results published in the Journal of Clinical Oncology (JCO). A total of 732 patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who progressed after endocrine therapy and had received one or two prior lines of chemotherapy were randomized 1:1 to datopotamab deruxtecan-dlnk (n=365) or investigator’s choice of chemotherapy (n=367), including eribulin, capecitabine, vinorelbine, or gemcitabine.

Datopotamab deruxtecan-dlnk significantly improved progression-free survival (PFS) with a median of 6.9 months versus 4.9 months for chemotherapy (HR 0.63; p < 0.0001). Median overall survival (OS) was 18.6 months versus 18.3 months (HR 1.01; not statistically significant). The confirmed objective response rate (ORR) was 36% versus 23%, with a median duration of response (DoR) of 6.7 months compared to 5.7 months.

The most common adverse reactions (≥20%) included stomatitis, nausea, fatigue, decreased leukocytes, alopecia, decreased hemoglobin, dry eye, vomiting, and elevated ALT/AST. The recommended dose is 6 mg/kg (up to 540 mg) intravenously every three weeks until disease progression or unacceptable toxicity.

Read more about FDA approval of datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer on OncoDaily.

What is Datroway and How does it work?

Datopotamab deruxtecan-dlnk, or Datroway, was developed by Daiichi Sankyo using its DXd antibody-drug conjugate (ADC) platform targeting Trop‑2. In 2020, Daiichi partnered with AstraZeneca (excluding Japan) to jointly develop and commercialize the drug, sharing research, development, and global commercialization responsibilities, while Daiichi handles manufacturing.

Datopotamab deruxtecan-dlnk is an ADC that combines a monoclonal antibody with a chemotherapy drug. The antibody targets Trop‑2, a protein on many cancer cells, including breast and lung tumors. Once bound, it delivers a topoisomerase I inhibitor directly into the cancer cell, damaging DNA and triggering cell death. This targeted approach reduces damage to healthy cells and improves treatment outcomes compared with traditional chemotherapy.

Learn more about Datopotamab Deruxtecan-dlnk (Datroway) Updates 2025: Uses in cancer, Side effects, Dosage, Expectations on OncoDaily.