DATROWAY Approved in China for Previously Treated HR+/HER2- Metastatic Breast Cancer

China’s National Medical Products Administration (NMPA) has approved DATROWAY (datopotamab deruxtecan) for the treatment of adults with unresectable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer who have previously received endocrine therapy and at least one line of chemotherapy.

DATROWAY is a TROP2-directed DXd antibody-drug conjugate (ADC) developed by Daiichi Sankyo and AstraZeneca, and represents a novel class of targeted therapy for a difficult-to-treat breast cancer subtype. The approval follows positive results from the global Phase 3 TROPION-Breast01 trial, which showed that DATROWAY significantly reduced the risk of disease progression or death by 37% compared to chemotherapy.

In the study, patients receiving DATROWAY had a median progression-free survival (PFS) of 6.9 months, versus 4.9 months for those receiving chemotherapy. The objective response rate (ORR) was also notably higher—36% vs. 23%, including two complete responses in the DATROWAY arm. While final overall survival (OS) data did not reach statistical significance, an exploratory analysis adjusting for subsequent ADC use suggested a potential OS benefit.

In the China-specific subgroup of the trial (83 patients), DATROWAY achieved a median PFS of 8.1 months, compared to 4.2 months with chemotherapy, and a confirmed ORR of 38.6%, reinforcing its efficacy in Chinese patients.

“Despite progress in treating HR+/HER2- metastatic breast cancer, many patients face limited options once their disease advances,” said Professor Binghe Xu, principal investigator in China for the TROPION-Breast01 trial. “This approval marks a meaningful step forward in expanding treatment choices.”

Michio Hayashi, President of Daiichi Sankyo China, added, “DATROWAY is now our second DXd ADC approved in China, following ENHERTU, and represents our continued commitment to addressing unmet needs in breast cancer.”

Dave Fredrickson, EVP at AstraZeneca, said, “We’re proud to bring this innovative TROP2-targeted therapy to patients in China who need more effective options after standard treatments.”

Breast cancer remains the second most common cancer in women in China, with an estimated 357,000 new cases and 75,000 deaths in 2022. Approximately 70% of breast cancers in China are classified as HR+/HER2-, the subgroup for which DATROWAY is now approved.

Common side effects reported in the trial included nausea, fatigue, stomatitis, low white blood cell counts, and dry eye. Serious (Grade 3 or higher) adverse events were rare but included interstitial lung disease, COVID-19 infection, and anemia. One patient died from treatment-related ILD.

The approval of DATROWAY offers a new, targeted treatment option for patients in China with advanced HR+/HER2- breast cancer, especially those who have exhausted other therapies.