Fonte: FirstWord Pharma
(Texto original, publicado em inglês)
Gilead nabs FDA priority review for Trodelvy in HR+/HER2- breast cancer
Gilead Sciences on Tuesday announced that Trodelvy (sacituzumab govitecan-hziy) has been granted a priority review by the FDA for another breast cancer indication. The designation is for a supplemental filing requesting that the Trop-2-directed antibody be approved for adults with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have progressed on endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Bill Grossman, the company’s therapeutic area head for oncology clinical development, 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.” A target action date has been set for February 2023.
The latest filing is based on data from the Phase III TROPiCS-02 study, which met its primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS) over physician’s choice of chemotherapy. In findings presented at this year’s American Society of Clinical Oncology (ASCO) meeting, Trodelvy reduced the risk of disease progression or death by 34%, with patients achieving median PFS of 5.5 months, which was 1.5 months longer than the comparator group. The drug was also associated with a 21% decrease in the risk of death, with the two groups surviving a median 14.4 months versus 11.2 months, respectively.
