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Gilead Trodelvy Has Shown Promise in Breast Cancer Patients’ Clinical Trials, Regardless of HER2 Mutation

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Regardless of the presence or absence of a HER2 mutation, Trodelvy improved progression-free survival (PFS) in patients with breast cancer, according to Gilead Sciences (NASDAQ:GILD).

Gilead Sciences (NASDAQ:GILD).

Gilead Sciences (NASDAQ:GILD) released data from a post hoc subgroup analysis from the phase 3 trial TROPiCS-02, which compared the effectiveness of Trodelvy (sacituzumab govitecan-hziy) and physicians’ choice of chemotherapy (TPC) in treating patients with HR+/HER2-metastatic breast cancer who had progressed after receiving at least two chemotherapies and endocrine-based treatments.


The data revealed that Trodelvy increased median PFS vs. TPC in both HER2-low (IHC1+ and IHC2+/ISH-negative) and IHC0 groups, the business said in a press release on September 5. PFS refers to the amount of time during or after treatment that a patient lives without the disease growing worse. 

According to Gilead, at a mini-oral session on September 10 during the European Society for Medical Oncology (ESMO) Congress 2022, detailed results will be given.

According to Bill Grossman, senior vice president, and therapeutic area head at Gilead Oncology, “Trodelvy is already revolutionizing the standard of care in second-line metastatic triple-negative breast cancer, and we’re excited about its potential in other breast cancers where there is a critical need for new treatment options.”

Application for Approval

No regulatory body has given Trodelvy the go-ahead to treat HR+/HER2-metastatic breast cancer. For this indication, its safety and efficacy have not been proven. Based on information from TROPiCS-02, Gilead has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). This information will also be distributed to health authorities outside of the U.S.

The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) now include sacituzumab govitecan. For use in adult patients with second-line metastatic triple-negative breast cancer, there is a Category 1 recommendation included in this (defined as those who received at least two prior therapies, with at least one line for metastatic disease). Additionally, it has a Category 2A preferred recommendation for usage in HR+/HER2- advanced breast cancer following prior therapy that included endocrine therapy, a CDK4/6 inhibitor, and at least two lines of chemotherapy. 

Featured Image-  Megapixl @Andreistanescu

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