FDA grants priority review to Trodelvy for pretreated metastatic breast cancer
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The FDA granted priority review to sacituzumab govitecan-hziy for treatment of certain patients with advanced breast cancer.
The designation applies to use of the agent by adults with unresectable locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer who received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) is a Trop-2-directed antibody-drug conjugate. The agent is approved in the United States for treatment of certain patients with metastatic triple-negative breast cancer or metastatic urothelial cancer.
A supplemental new drug application for the additional breast cancer indication is based on results of the randomized phase 3 TROPiCS-2 study, which included 543 patients with hormone receptor-positive, HER2-negative metastatic breast cancer who previously received endocrine therapy, cyclin-dependent kinase 4/6 inhibitors, and two to four lines of chemotherapy for metastatic disease.
Researchers randomly assigned patients 1:1 to sacituzumab govitecan-hziy or physician’s choice of chemotherapy, which included eribulin, capecitabine, gemcitabine or vinorelbine.
As Healio previously reported, the study met its primary endpoint, showing improved PFS per blinded independent central review among patients assigned sacituzumab govitecan-hziy (median, 5.5 months vs. 4 months; HR = 0.66; 95% CI, 0.53-0.83). Researchers also reported improved OS — one of four secondary endpoints — in the sacituzumab govitecan-hziy group (median, 14.4 months vs. 11.2 months; HR = 0.78; 95% CI, 0.64-0.96).
Sacituzumab govitecan-hziy exhibited a safety profile consistent with that observed in prior studies. The agent has a boxed warning for severe or life-threatening neutropenia and severe diarrhea.
The FDA is expected to make a decision about approval of sacituzumab govitecan-hziy for this indication by February.
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