DATROWAY® Approved in U.S. for Metastatic HR+ HER2- Breast Cancer

In a significant development within the oncology field, the U.S. Food and Drug Administration (FDA) has approved DATROWAY® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with advanced hormone receptor (HR) positive, HER2 negative breast cancer. This approval marks an important step for patients whose cancer has not responded to previous endocrine-based therapies and chemotherapy.

DATROWAY is a TROP2 directed antibody drug conjugate (ADC), designed through Daiichi Sankyo's DXd ADC Technology, and jointly developed by Daiichi Sankyo and AstraZeneca. This approval is based on results from the TROPION-Breast01 phase 3 trial, which showed a notable improvement in progression-free survival among patients treated with DATROWAY compared to those receiving standard chemotherapy.

The phase 3 clinical trial demonstrated that DATROWAY significantly reduced the risk of disease progression or death by 37% against the control group receiving alternative chemotherapy treatments. The median progression-free survival for patients on DATROWAY was 6.9 months, in comparison to 4.9 months for those on chemotherapy. Moreover, DATROWAY exhibited a confirmed objective response rate of 36% compared to 23% with chemotherapy, indicating a more effective response in managing the disease.

Dr. Aditya Bardia from UCLA Health Jonsson Comprehensive Cancer Center highlighted that the approval introduces a new treatment avenue for patients, emphasizing its potential to address treatment-resistant cases after conventional therapies have been exhausted. Caitlin Lewis from Living Beyond Breast Cancer also noted the importance of this approval, as current options for HR positive, HER2 negative metastatic breast cancer are limited, with only a small fraction of patients surviving beyond five years post-diagnosis.

In terms of safety, DATROWAY's side effects were evaluated in a cohort of 360 patients. Common adverse effects included stomatitis, nausea, fatigue, and other laboratory abnormalities, with some serious adverse reactions reported, including urinary tract infections and interstitial lung disease, among others.

Ken Keller, President and CEO of Daiichi Sankyo, Inc., expressed that the approval of DATROWAY represents an expansion in their oncology treatment offerings, providing an innovative alternative for patients. Meanwhile, AstraZeneca's Dave Fredrickson underlined the company's commitment to advancing ADCs as a superior option over traditional chemotherapy for various cancers.

Following this approval, DATROWAY will become available by prescription in the U.S., with Daiichi Sankyo and AstraZeneca ensuring that patients can access the medication along with necessary financial support. Regulatory submissions for DATROWAY are also under consideration in other regions, including the EU and China.

The TROPION-Breast01 trial was a comprehensive global study involving 732 patients across several continents, assessing DATROWAY's efficacy and safety compared to chemotherapy options such as eribulin and capecitabine. The study's primary endpoints included progression-free survival and overall survival, with additional analyses addressing response rates and safety.

As part of a larger clinical development program, DATROWAY is being evaluated across various cancer types, including lung and other breast cancer subtypes, with extensive trials underway. The collaboration between Daiichi Sankyo and AstraZeneca illustrates a strategic effort to advance cancer treatment options through innovative ADC technology.

Overall, the introduction of DATROWAY offers a promising new therapy for patients facing advanced HR positive, HER2 negative breast cancer, providing a potential breakthrough for those with limited treatment options.