The FDA issued an Oct. 18 reminder to the diagnostics industry that the agency still requires test developers to register with an institutional review board (IRB) for all studies of human subjects. This still pertains to studies that make use of leftover, de-identified specimens in FDA-regulated studies, an alert to industry which suggests that enforcement actions may be in the near offing.
The Menarini Group and Radius Health Inc.’s phase III Emerald study of oral elacestrant as a monotherapy vs. standard of care in treating estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer hit its two primary endpoints. The study’s top-line data, according to the companies, showed statistically significant progression-free survival in both the overall population and in patients with tumors harboring estrogen receptor 1 mutations.
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