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.
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