Action Date Set for Gilead Sciences’ HR+/HER2- breast cancer sBLA

The United States Food and Drug Administration (FDA) accepted Gilead Sciences’ supplemental Biologics License Application (sBLA) for Trodelvy (sacituzumab govitecan-hziy) for priority review. With approvals in over thirty-five countries, this sBLA expands the breast cancer treatment’s use for unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative. 

The basis of the sBLA is the Phase 3 TROPiCS-02 study, which saw a significant reduction in the risk of disease progression or death.

Related Article: Roche’s Newly Approved Companion Diagnostic May Open Treatment Options for HER2-low Patients

The Expanded Use of Trodelvy

Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate for the treatment of various forms of cancer. Originally, the drug won approval for treating previously-treated metastatic triple-negative breast cancer (TNBC) in April 2020. A year later, the FDA granted Trodelvy approval as a first treatment for TNBC, with approval for use as a urothelial cancer (UC) treatment coming just days later. 

Earlier this year, Gilead announced topline results from the TROPiCS-02 study, which compared Trodelvy to other chemotherapies in treating HR+/HER2- breast cancer. Though HER2- cancer lacks the levels of the protein used for targeted therapies, emerging drugs instead target the HER2 receptors. Another example of this is AstraZeneca and Merck’s LYNPARZA® (olaparib). The other therapies viewed in the study included eribulin, capecitabine, gemcitabine, and vinorelbine. 

Published in the Journal of Clinical Oncology, TROPiCS-02 demonstrated a 34% reduction in risk of disease progression or death along with a consistent safety profile with prior studies. 

With the results from TROPiCS-02, Gilead submitted an sBLA for Trodelvy’s expanded use for HR+/HER2- breast cancer. After a few months, the FDA accepted the sBLA, granting it priority review.

On the acceptance, Bill Grossman, MD, PhD, Senior Vice President and Therapeutic Area Head at Gilead Oncology, said, “People with pre-treated HR+/HER2- metastatic breast cancer who have progressed on endocrine-based therapies and chemotherapy have limited treatment options, and we look forward to working with the FDA to potentially make Trodelvy available to patients who need it most.”

Currently, Trodelvy has no approval for HR+/HER2- metastatic breast cancer from any regulatory agency. However, the target action date for a decision on the sBLA is set for February 2023. Potentially, that is the date when Trodelvy gains yet another approval. 

Author

Max Heirich