On Thursday, the U.S. Food and Drug Administration (FDA) approved Eli Lilly and Co.’s (NYSE: LLY) Inluriyo (imlunestrant) for adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).
The FDA approval is based on the results of the EMBER-3 trial in the patient population harboring ESR1-mutated MBC (n=256).
In the Phase 3 EMBER-3 trial, Inluriyo reduced the risk of progression or death by 38% versus ET.
Among patients with ESR1-mutated MBC, Inluriyo significantly improved progression-free survival (PFS) versus fulvestrant or exemestane, with a median PFS of 5.5 months vs 3.8 months.
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Inluriyo is a treatment for ER+, HER2–, ESR1-mutated MBC. Some breast cancers develop ESR1 mutations that can cause estrogen receptors to become overactive and drive cancer growth.
Inluriyo binds, blocks, and facilitates the degradation of these receptors, helping to slow disease progression. Its once-daily dosing provides patients with an oral treatment option.
Inluriyo is also being studied in the ongoing Phase 3 EMBER-4 trial in the adjuvant setting for people with ER+, HER2– early breast cancer (EBC) at increased risk of recurrence, which is enrolling approximately 8,000 patients worldwide.
Inluriyo is expected to be available in the United States in the coming weeks.
Other Drug Approval
Also, on Thursday, the European Commission approved Eli Lilly’s Kisunla (donanemab) for the treatment of early symptomatic Alzheimer’s disease (AD) in adults with mild cognitive impairment, as well as those with mild dementia stages of AD with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
Data has also shown that Kisunla can significantly reduce the risk of progressing to the next clinical stage of disease over 18 months.
The Kisunla marketing authorization in the European Union is based on the TRAILBLAZER-ALZ 2 and the TRAILBLAZER-ALZ 6 clinical trials.
The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated Kisunla significantly slowed cognitive and functional decline.
The dosing schedule is based on the Phase 3b TRAILBLAZER-ALZ 6 study, which demonstrated that the incidence of ARIA-E was significantly lowered at 24 and 52 weeks using a more gradual titration dosing schedule versus the dosing schedule used in TRAILBLAZER-ALZ 2.
This gradual dosing increase still achieved similar levels of amyloid plaque removal and P-tau217 reduction.
Price Action: LLY stock is up 1.53% at $725.50 during the premarket session at the last check on Friday.
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