Datroway approved in US: A new era in metastatic breast cancer treatment

In a landmark decision, the US Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan), a first-in-class TROP2-directed antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo. This approval marks a significant milestone for the treatment of metastatic hormone receptor (HR)-positive, HER2-negative breast cancer, a subtype known for its aggressive progression and limited treatment options in advanced stages.

Datroway is designed for adult patients whose breast cancer is unresectable or metastatic and who have undergone prior endocrine-based therapy and chemotherapy. The FDA’s decision is grounded in compelling clinical data from the TROPION-Breast01 Phase III trial, which demonstrated the therapy’s ability to significantly delay disease progression compared to standard chemotherapy.

How Does Datroway Improve Breast Cancer Treatment?

Metastatic HR-positive, HER2-negative breast cancer affects approximately 70% of all breast cancer patients, making it the most common subtype. Despite progress in early detection and treatment, metastatic cases remain a leading cause of breast cancer-related mortality. Traditional therapies, including endocrine treatments and chemotherapy, often fail to control the disease in its later stages, creating a critical need for innovative alternatives.

Datroway offers a targeted approach by utilising antibody-drug conjugate (ADC) technology. This precision therapy delivers a cytotoxic agent directly to cancer cells expressing TROP2, a protein associated with tumour growth. The result is a more focused attack on cancer cells while minimising damage to healthy tissue.

Dr. Aditya Bardia, Program Director of Breast Oncology at UCLA Health and the global principal investigator for the TROPION-Breast01 trial, highlighted Datroway’s potential:

“Metastatic HR-positive, HER2-negative breast cancer often resists standard treatments. The approval of Datroway introduces a much-needed alternative that directly addresses the challenge of disease progression.”

What Did the TROPION-Breast01 Trial Reveal About Datroway?

The FDA’s approval of Datroway was primarily based on the findings from the TROPION-Breast01 trial, a global Phase III study involving 732 patients across North America, Europe, Asia, and South America. The trial compared Datroway’s efficacy and safety against chemotherapy options commonly used in metastatic breast cancer treatment.

Key findings include:

• Progression-Free Survival (PFS): Patients receiving Datroway achieved a median PFS of 6.9 months, compared to 4.9 months for those treated with chemotherapy.
• Risk Reduction: Datroway reduced the risk of disease progression or death by 37% compared to chemotherapy (hazard ratio [HR] 0.63; 95% confidence interval [CI] 0.52-0.76; p<0.0001).

The trial also demonstrated a manageable safety profile, with no unexpected adverse events. Interstitial lung disease (ILD) was reported in 4.2% of patients, with most cases being low-grade and treatable.

Why Is Datroway a Milestone for AstraZeneca and Daiichi Sankyo?

Datroway is the eighth new therapy introduced by AstraZeneca as part of its ambitious goal to launch 20 innovative treatments by 2030. The drug exemplifies the success of AstraZeneca’s collaboration with Daiichi Sankyo, which began in 2020 to develop TROP2-directed ADCs for multiple cancer types.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, expressed pride in this achievement:

“This approval reflects our commitment to improving cancer care through antibody-drug conjugates. Datroway’s ability to outperform conventional chemotherapy reaffirms our focus on advancing targeted therapies.”

Similarly, Ken Keller, CEO of Daiichi Sankyo, emphasised the importance of Datroway in the company’s oncology pipeline, noting that it is the fourth innovative cancer treatment from their portfolio to receive FDA approval.

What Does This Mean for Patients with Metastatic Breast Cancer?

Metastatic breast cancer remains one of the most challenging oncology diagnoses. In the US, over 300,000 cases of breast cancer are diagnosed annually, with only 30% of metastatic patients surviving beyond five years.

Caitlin Lewis, Senior Vice President at Living Beyond Breast Cancer, underscored the urgency of introducing new therapies:

“Datroway offers hope for patients who have exhausted other treatment options. Its approval marks a significant advance in the fight against metastatic breast cancer.”

With Datroway now available in the US, patients have access to a therapy that not only improves survival outcomes but also enhances quality of life by reducing reliance on traditional chemotherapy.

What’s Next for Datroway?

Regulatory submissions for Datroway are under review in major global markets, including the European Union and China. These submissions reflect AstraZeneca’s and Daiichi Sankyo’s commitment to making the drug accessible worldwide.

Beyond breast cancer, Datroway is being evaluated in over 20 clinical trials targeting multiple cancers, including non-small cell lung cancer and triple-negative breast cancer. This comprehensive development programme positions Datroway as a key player in the future of oncology.