29 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 NEWS Eli Lilly announced U.S. FDA approval of imlunestrant, its treatment for adults with ER+, HER2-, ESR1mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy, on September 25th. Marketed as Inluriyo, imlunestrant is an oral estrogen receptor antagonist treatment delivered via 200 mg tablets. According to a company press release, FDA approval was based on results from the Phase III EMBER-3 clinical trial. The study evaluated treatment of individuals with ESR1mutated metastatic breast cancer with imlunestrant as both a first- and second-line treatment. Study results found that patients with ESR1-mutated metastatic breast cancer who were given imlunestrant had significantly improved median progression-free survival (5.5 months) versus patients dosed with fulvestrant or exemestane (3.8 months). “This therapy reflects our commitment to developing treatments that improve outcomes for people with breast cancer and represents an important step toward advancing innovative, all-oral treatment approaches,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology, in the press release. “We are deeply grateful to the patients, investigators, Lilly team members and clinical care teams who made this advancement possible. This therapy has the potential to make the treatment journey more manageable for those living with breast cancer.” “This represents an important advancement for patients with ESR1mutated [metastatic breast cancer], a mutation found in nearly half of patients who have taken hormone therapies, often contributing to treatment resistance,” said Komal Jhaveri, section head of Endocrine Therapy Research and clinical director of Early Drug Development at Memorial Sloan Kettering Cancer Center, and a principal investigator of EMBER-3, in the press release. “With its demonstrated efficacy, tolerability profile and oral administration, this therapy provides a meaningful alternative treatment option for this patient population.” Imlunestrant is also currently being evaluated in the Phase III EMBER-4 trial in the adjuvant setting for people with ER+, HER2– early breast cancer who are at increased risk of recurrence. It is enrolling approximately 8,000 patients worldwide. FDA approves Eli Lilly oral breast cancer treatment
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