Gilead gets Trodelvy FDA priority review for pre-treated HR+/HER2- metastatic breast cancer

Gilead Sciences said that Trodelvy (sacituzumab govitecan-hziy) has been granted priority review from the US Food and Drug Administration (FDA) for the treatment of another type of metastatic breast cancer.

The supplemental biologics license application (sBLA) filed by Gilead Sciences is for using the breast cancer drug in adults having unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who were previously given endocrine-based therapy and at least a couple of additional systemic therapies in the metastatic setting.

Trodelvy, which is an antibody-drug conjugate (ADC) targets a cell surface antigen called Trop-2, which is expressed highly in various types of tumors. The Gilead breast cancer drug is approved in more than 35 countries for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adults who have been given two or more prior systemic therapies, with at least one of them for metastatic disease.

Besides, Trodelvy has another approval in the US under the accelerated approval pathway for the treatment of adults having locally advanced or metastatic urothelial cancer (UC) who were previously subjected to a platinum-containing chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Gilead Sciences gets Trodelvy FDA priority review for pre-treated HR+/HER2- metastatic breast cancer. Photo courtesy of Marijana from Pixabay.

Bill Grossman — Gilead Sciences Senior Vice President and Oncology Therapeutic Area Head said: “Trodelvy has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and today’s news marks our third supplemental application acceptance within the last two years.

“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.”

According to Gilead Sciences, Trodelvy sBLA for pre-treated HR+/HER2- metastatic breast cancer includes data from the phase 3 TROPiCS-02 study. The late-stage clinical trial met its primary endpoint of progression-free survival (PFS) as well as the key secondary endpoint of overall survival (OS) over comparator chemotherapy.