EC Approves AstraZeneca/Daiichi Sankyo's Datroway for Breast Cancer

The European Commission (EC) has recently approved AstraZeneca (AZ) and Daiichi Sankyo's drug, Datroway (datopotamab deruxtecan), for specific cases of pre-treated breast cancer. This decision pertains to adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have already undergone endocrine therapy and at least one chemotherapy regimen in advanced stages.

This approval is a result of a recommendation from the European Medicines Agency's human medicines committee, bolstered by findings from the phase 3 TROPION-Breast01 trial. The trial demonstrated that intravenous Datroway reduced the risk of disease progression or death by 37% when compared to the chemotherapy options available to the investigators. Notably, the median progression-free survival rate for patients receiving Datroway was 6.9 months, as opposed to 4.9 months for those undergoing chemotherapy.

Moreover, the trial revealed a confirmed objective response rate of 36% among the Datroway group, compared to 23% in the chemotherapy group. The median duration of response also favored Datroway, with a duration of 6.7 months, compared to 5.7 months for chemotherapy.

Breast cancer affects approximately 557,000 individuals annually in Europe, with HR-positive, HER2-negative types comprising about 70% of these cases. Typically, endocrine therapies are employed in the initial stages for HR-positive metastatic breast cancer. However, their effectiveness diminishes over time, at which point chemotherapy, known for its suboptimal response rates and outcomes, becomes the standard treatment.

Datroway represents a new class of cancer drugs known as antibody-drug conjugates. These innovative treatments harness the specificity of antibodies combined with the lethal capabilities of chemotherapy or other cancer-fighting agents. Datroway is engineered to target TROP2-expressing tumor cells, and it was originally discovered by Daiichi Sankyo. AstraZeneca and Daiichi Sankyo are jointly involved in its development and commercialization.

Dave Fredrickson, the executive vice president of the oncology hematology business unit at AZ, emphasized the significance of this approval. He pointed out that despite advancements in the treatment of HR-positive breast cancer, progression on frontline therapies remains a significant and intricate issue for patients with metastatic disease. With Datroway's approval, patients in the EU suffering from HR-positive, HER2-negative breast cancer now have a fresh and necessary alternative to traditional chemotherapy options.

This development is a significant step forward in offering more effective treatment options for patients in Europe, potentially improving outcomes for those with advanced stages of breast cancer. As the healthcare community continues to explore innovative solutions, Datroway stands as a promising new option in the landscape of cancer treatment, providing hope for better management of this prevalent disease.