The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for sacituzumab govitecan-hziy for the treatment of adults with unresectable, locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. 

Sacituzumab govitecan is a Trop-2-directed antibody and topoisomerase inhibitor conjugate.

The sBLA for sacituzumab govitecan is supported by data from the phase 3 TROPiCS-02 study (ClinicalTrials.gov Identifier: NCT03901339). The study was designed to evaluate sacituzumab govitecan in 543 patients with HR+/HER2- metastatic breast cancer who were previously treated with endocrine therapy, CDK4/6 inhibitors, and 2 to 4 lines of chemotherapy for metastatic disease.


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Patients were randomly assigned 1:1 to receive sacituzumab govitecan or physician’s choice of chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine). The primary endpoint was progression-free survival (PFS). 

Treatment with sacituzumab govitecan met the primary endpoint, demonstrating a 34% reduction in the risk of progression or death compared with chemotherapy (median PFS: 5.5 months and 4 months, respectively; hazard ratio [HR], 0.66; 95% CI, 0.53-0.83; P =.0003).

Moreover, sacituzumab govitecan was associated with a statistically significant and clinically meaningful improvement in overall survival vs chemotherapy (median overall survival: 14.4 months and 11.2 months, respectively; HR, 0.79; 95% CI, 0.65-0.96; P =.02).

The safety profile of sacituzumab govitecan was consistent with that seen in previous studies. No new safety signals were identified.

The prescription drug user fee act target date for the sBLA is February 2023.

Sacituzumab govitecan is currently marketed under the brand name Trodelvy for the treatment of adults with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who have received 2 or more prior systemic therapies, at least 1 of them for metastatic disease.

Trodelvy is also indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor.

References

  1. US FDA accepts for priority review the supplemental biologics license application for Gilead’s Trodelvy® for pre-treated HR+/HER2- metastatic breast cancer. News release. Gilead Sciences, Inc. Accessed October 11, 2022. https://www.businesswire.com/news/home/20221010005766/en/U.S.-FDA-Accepts-for-Priority-Review-the-Supplemental-Biologics-License-Application-for-Gilead%E2%80%99s-Trodelvy%C2%AE-for-Pre-Treated-HRHER2–Metastatic-Breast-Cancer
  2. Rugo HS, Bardia A, Marme F, et al. Sacituzumab govitecan in hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer. Journal of Clinical Oncology. Published online August 26, 2022. doi:10.1200/JCO.22.01002 

This article originally appeared on MPR