Gilead Submits Approval Application for Trodelvy in Treating HR-/HER2- Breast Cancer

Gilead Sciences, based in Chiyoda, Tokyo, has announced the submission of an application for expanded approval of Trodelvy (sacituzumab govitecan), specifically targeting patients with hormone receptor-negative (HR-) and HER2-negative (HER2-) breast cancer who are unable to receive immunotherapy. This application is a pivotal step in offering effective treatment options for patients suffering from this aggressive form of breast cancer, which accounts for approximately 10% of all cases.

Understanding HR-/HER2- Breast Cancer

HR-/HER2- breast cancer is recognized for its high malignancy and presents a limited array of treatment alternatives compared to other breast cancer types. The absence of estrogen and progesterone receptors, coupled with minimal or no expression of HER2, makes it particularly challenging to treat. Patients with this breast cancer subtype often face a higher risk of recurrence and metastasis, leading to an urgent need for innovative therapeutic strategies.

The approval application drew from a recent international Phase III trial (GS-US-592-6238 trial, ASCENT-03), which evaluated the efficacy and safety of administering Trodelvy alongside physician-chosen chemotherapy in patients without prior treatment for advanced breast cancer, with a focus on those with conditions that prohibit the use of PD-1/PD-L1 inhibitors. The trial serves as a crucial basis for Gilead's application amid the pressing demand for effective treatments for this vulnerable patient population.

Trodelvy: An Innovative Treatment Option

Trodelvy has distinguished itself as the first antibody-drug conjugate (ADC) targeting the TROP-2 protein approved globally, providing a novel treatment option for chemotherapy-experienced patients with HR-/HER2- breast cancer. It has already secured approval in Japan and 56 other countries, demonstrating its potential in addressing the critical needs of breast cancer treatment. Furthermore, Gilead is also pursuing additional indications for Trodelvy, including HR+/HER2- breast cancer, expected to be evaluated for expanded approval in the near future.

As part of its commitment to making strides in oncology and other challenging medical conditions, Gilead Sciences has continually prioritized research and innovation over its 30-year history. The company is dedicated not only to developing groundbreaking therapies for life-threatening diseases but also to ensuring that these innovations reach patients worldwide.

Gilead's Commitment to Innovation

Gilead strives to maintain a healthier world for all, ensuring that the benefits of scientific innovation are extended globally. The company announced a substantial investment plan of $320 billion by 2025 to bolster its presence in the United States and enhance public health solutions, with a focus on addressing pressing medical challenges such as cancer, infectious diseases, and inflammatory conditions. With its headquarters in Foster City, California, Gilead operates across more than 35 countries, emphasizing its role as a leader in biopharmaceutical advancements and patient care initiatives.

In summary, Gilead Sciences’ submission for Trodelvy as a treatment for HR-/HER2- breast cancer represents a significant development in the fight against one of the most challenging cancer subtypes. The ongoing efforts to expand treatment options reflect Gilead's commitment to improving patient outcomes and evolving cancer care methodologies.