The FDA has approved Eli Lilly’s imlunestrant, an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed following at least one prior endocrine therapy.
The approval is based on results from a phase 3 trial, which included 874 patients. Among 256 patients with ESR1 mutations, imlunestrant showed a median progression-free survival of 5.5 months, compared to 3.8 months with standard endocrine therapies, according to a Sept. 25 news release from the agency.
The drug also showed a higher objective response rate of 14.3% with imlunestrant, compared to 7.7% for the comparison group, the release said.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
