#Japan #Breast Cancer #Gilead #Trodelvy #Chiyoda, Tokyo

Gilead's Innovative Step in Breast Cancer Treatment

Gilead Sciences, headquartered in Chiyoda, Tokyo, has recently announced a significant development in the oncology field. The company has submitted an application to the Japanese Ministry of Health, Labor and Welfare for the addition of Trodelvy (generic name: sacituzumab govitecan), an antibody-drug conjugate (ADC), as a first-line treatment for PD-L1-positive, hormone receptor-negative, and HER2-negative (HR-/HER2-) unresectable or recurrent breast cancer, in combination with Keytruda (generic name: pembrolizumab).

This application targets patients who have no prior treatment history for advanced breast cancer and are suffering from PD-L1-positive HR-/HER2- locally advanced or metastatic breast cancer. The submission is based on the results of a randomized, open-label international Phase III clinical trial (GS-US-592-6173, ASCENT-04/KEYNOTE-D19), which compares the combination therapy of sacituzumab govitecan and pembrolizumab to chemotherapy plus pembrolizumab chosen by the physicians.

Notably, this recent application follows another one submitted for immune therapy in February 2026 for hormone receptor-negative and HER2-negative unresectable or recurrent breast cancer which does not qualify for that approval. The evolution of treatment options is particularly crucial as HR-/HER2- breast cancer, often referred to as triple-negative breast cancer (TNBC), is known for its aggressive nature, high recurrence rates, and limited treatment possibilities.

The patient population suffering from PD-L1-positive HR-/HER2- breast cancer has a pressing need for effective long-term treatment options. Presently, the combination of chemotherapy and immunotherapy is used as one of the initial treatment regimens. However, many details about the durability of this treatment's effects and the options available when the disease progresses are still not well understood, leaving doctors to navigate uncertain choices regarding patient care. Therefore, expanding treatment options from the outset can broaden future therapeutic avenues and potentially tailor healthcare to individual patient needs. This initiative represents a significant stride towards addressing unresolved challenges faced by patients with this complex disease.

Trodelvy's current approvals in Japan include two indications:

• - Approved on September 24, 2024, for "unresectable or recurrent breast cancer with no prior chemotherapy history, hormone receptor-negative, and HER2-negative."
• - Approved on March 23, 2026, for "unresectable or recurrent breast cancer with hormone receptor-positive and HER2-negative, having a prior chemotherapy history."

Furthermore, both the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency) have accepted Gilead's application for this additional indication.

Understanding HR-/HER2- Breast Cancer

HR-/HER2- breast cancer, defined as having an IHC score of 0, 1+, or ISH negative, is a highly malignant subtype comprising roughly 10% of all breast cancers. These tumor cells lack receptors for estrogen and progesterone and exhibit limited to no expression of HER2 (human epidermal growth factor receptor 2). Due to its inherent characteristics, effective treatment options for HR-/HER2- breast cancer are scarce, contributing to its heightened rates of relapse and metastasis.

About Trodelvy

Trodelvy is the only ADC that has yielded positive results in four Phase III trials for HER2-negative refractory breast cancer. It demonstrates a statistically significant overall survival extension for patients with a history of chemotherapy and recurrent HR-/HER2- breast cancer as well as for those with recurrent hormone receptor-positive and HER2-negative breast cancer. Importantly, it serves as the only ADC targeting TROP-2 protein. Over the past five years, Trodelvy has been administered to more than 60,000 patients across more than 60 countries, including Japan, consistently showing efficacy.

Gilead Sciences: An Overview

Gilead Sciences has relentlessly pursued medical innovations for over 35 years with a mission to create a healthier world for all. The biopharmaceutical company focuses on the prevention and treatment of life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammatory conditions. To ensure its groundbreaking scientific advancements benefit patients globally, Gilead continues to invest heavily in future scientific discoveries, job creation, and public health preparedness, announcing a substantial $320 billion investment plan in 2025 aimed at bolstering its U.S. operational base. Headquartered in Foster City, California, Gilead operates in more than 35 countries worldwide.