#Japan #Tokyo #Trodelvy #Gilead Sciences #HR+/HER2-

Gilead Sciences Expands Trodelvy Indications for Breast Cancer

Gilead Sciences, headquartered in Chiyoda, Tokyo, has received additional approval for its antibody-drug conjugate, Trodelvy (sacituzumab govitecan), specifically for the treatment of patients with inoperable or recurrent HR+/HER2- breast cancer who have a history of chemotherapy. This new indication is a significant step forward, expanding the options available for patients in need of advanced therapy.

Trodelvy's approval was based on positive outcomes from the TROPiCS-02 Phase III trial conducted overseas, alongside results from the domestic ASCENT-J02 Phase I/II trial focusing on the HR+/HER2- breast cancer cohort. The indications were submitted for approval on April 24, 2025, targeting patients with HR+/HER2- breast cancer who have already undergone treatments including endocrine therapies, CDK4/6 inhibitors, and taxanes.

Significance of the Approval

This marks Trodelvy's second indication, following the approval in September 2024 for patients with chemotherapy history of hormone receptor-negative (HR-/HER2-) breast cancer. According to Professor Shingo Masuda from Kyoto University's Graduate School of Medicine, the ability to use Trodelvy for HR+/HER2- breast cancer in Japan is a welcome development. He emphasized that this advancement provides a much-needed treatment option for patients who have shown resistance to endocrine therapy.

Gilead Sciences' President, Kenji Breisting, expressed satisfaction with this expanded approval, highlighting the anticipation for Trodelvy to be available for HR+/HER2- patients in addition to those with the previously approved HR-/HER2- category. Notably, Trodelvy was the first ADC approved targeting the TROP-2 protein, which is essential for advancing treatment options for various cancers. Furthermore, the drug is already authorized in more than 50 countries worldwide for this indication.

Understanding HR+/HER2- Breast Cancer

HR+/HER2- breast cancer is the most prevalent type, accounting for approximately 75% of all breast cancer cases. When patients demonstrate resistance to endocrine therapies, chemotherapy remains the primary treatment option. Despite multiple chemotherapy regimens, prognosis remains challenging.

Key Clinical Trials

The TROPiCS-02 trial enrolled 543 HR+/HER2- breast cancer patients who had received two or more prior chemotherapy regimens. This randomized, investigator-selected study compared the effectiveness and safety of Trodelvy (272 patients) versus physician's choice of treatment (271 patients). The results showed a statistically significant improvement in progression-free survival for patients treated with Trodelvy compared to the control group. The median follow-up for survival outcomes in the Trodelvy cohort was 13.8 months, with some common adverse effects including neutropenia, diarrhea, nausea, alopecia, fatigue, and anemia.

Additionally, the ASCENT-J02 study evaluated Trodelvy’s safety and efficacy in 42 HR+/HER2- patients who had a similar treatment history, confirming the promising results from the TROPiCS-02 study.

What is Trodelvy?

Trodelvy is a first-in-class ADC designed to target TROP-2, a surface antigen that is often highly expressed in various cancers, including breast and lung cancers. By using a proprietary hydrolysable linker attached to SN-38, a topoisomerase I inhibitor, Trodelvy effectively kills tumor cells expressing TROP-2, exhibiting powerful antitumor activity even in the surrounding tumor microenvironment.

Currently, Trodelvy is approved in over 60 countries for treating advanced, inoperable triple-negative breast cancer (TNBC) after second-line therapy, and in over 50 countries for specific patients with HR+/HER2- breast cancer with prior treatment history. Ongoing Phase III trials are further examining Trodelvy’s efficacy across different cancers exhibiting high TROP-2 expression.

About Gilead Sciences

Founded over 35 years ago, Gilead Sciences is dedicated to advancing health through medical innovation. The company focuses on developing treatments for life-threatening diseases such as HIV, viral hepatitis, COVID-19, cancer, and inflammatory disorders. With a commitment to ensuring global access to its innovative drugs, Gilead has announced a major $320 billion investment plan aimed at strengthening its presence in the U.S. and supporting public health advancements.

As the landscape of breast cancer treatment continues to evolve, Trodelvy's additional approval represents a vital resource for healthcare providers and patients alike, offering a glimmer of hope and a path forward in oncology care.

Conclusion

Gilead Sciences' addition of Trodelvy's indications underscores the importance of innovative therapeutics in the fight against cancer. The collective efforts of medical researchers, clinicians, and the company are vital in navigating the complexities of HR+/HER2- breast cancer treatment, paving the way for improved patient outcomes in the future.