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The new approval expands the drug's indication to include treatment in adult patients with unresectable locally advanced or metastatic triple-negative breast cancer.
Gilead’s Trodelvy (sacituzumab govitecan-hziy), received full FDA approval and an expanded indication for patients with advanced or metastatic triple-negative breast cancer (TNBC).
The FDA granted accelerated approval to Trodelvy a year ago, but the new approval expands the drug's indication to include treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The commercial list price or Trodelvy is around $2,100 per vial, a spokesperson told FormularyWatch®. The cost of therapy is dependent on patient weight and duration of treatment, the spokesperson said.
Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse, Gilead said in a press release. Prior Trodelvy’s approval, patients with previously treated metastatic TNBC had few treatment options, according to Gilead.
“Women with triple-negative breast cancer have historically had very few effective treatment options and faced a poor prognosis,” said Aditya Bardia, MD, MPH, director of Breast Cancer Research Program, Mass General Cancer Center; assistant professor of medicine at Harvard Medical School, and global principal investigator of the ASCENT study.“[FDA’s] approval reflects the statistically significant survival benefit seen in the landmark ASCENT study and positions sacituzumab govitecan-hziy as a potential standard of care for pre-treated TNBC.”
In the Phase 3 ASCENT study, Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS), extending median PFS to 4.8 months from 1.7 months with chemotherapy.
Trodelvy also extended median overall survival (OS) to 11.8 months versus 6.9 months, a 49% reduction in the risk of death.
Trodelvy carries a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea.