FDA approves Lilly’s Inluriyo for ESR1-mutated breast cancer

INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY), a prominent player in the pharmaceutical industry with a market capitalization of $641 billion, has received U.S. Food and Drug Administration approval for Inluriyo (imlunestrant), an oral treatment for adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. According to InvestingPro data, the company maintains an impressive 82.6% gross profit margin and has shown strong revenue growth of 37% over the last twelve months.

In the Phase 3 EMBER-3 clinical trial, Inluriyo reduced the risk of disease progression or death by 38% compared to standard endocrine therapy. The median progression-free survival was 5.5 months for Inluriyo versus 3.8 months for fulvestrant or exemestane.

The FDA approval is based on results from 256 patients with ESR1-mutated metastatic breast cancer in the EMBER-3 trial. Participants received either Inluriyo or endocrine therapy as first-line treatment following recurrence on adjuvant aromatase inhibitor therapy (21% of patients) or as second-line treatment following progression on aromatase inhibitors (79% of patients).

"This represents an important advancement for patients with ESR1-mutated MBC, a mutation found in nearly half of patients who have taken hormone therapies, often contributing to treatment resistance," said Dr. Komal Jhaveri from Memorial Sloan Kettering Cancer Center, a principal investigator of EMBER-3, according to the company’s press release.

The most common adverse reactions in the trial included decreased hemoglobin, musculoskeletal pain, decreased calcium, decreased neutrophils, increased liver enzymes, fatigue, diarrhea, and nausea. The company reported that 4.6% of patients discontinued treatment due to adverse events.

Inluriyo is administered as a once-daily oral dose of 400 mg (two 200 mg tablets) taken on an empty stomach.

The company stated that Inluriyo is expected to be available in the United States in the coming weeks. The drug is also being studied in the ongoing Phase 3 EMBER-4 trial for early breast cancer patients at increased risk of recurrence. With an "GREAT" financial health score from InvestingPro and strong analyst support (14 analysts recently revised earnings upward), Eli Lilly continues to demonstrate robust market positioning. For deeper insights into Eli Lilly’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

In other recent news, Eli Lilly announced plans to invest $6.5 billion in a new manufacturing facility in Houston, Texas. The site, focused on producing small molecule synthetic medicines, is expected to create 615 permanent jobs and about 4,000 construction positions. Additionally, Eli Lilly’s diabetes medication Mounjaro showed promising results in a pediatric diabetes trial, significantly improving blood sugar control and reducing body mass index in children and adolescents. The trial’s primary endpoint was met, with Mounjaro reducing A1C levels by an average of 2.2% from baseline.

Furthermore, Cantor Fitzgerald reiterated an Overweight rating on Eli Lilly, citing consistent clinical trial data that was well-received by medical professionals. Bernstein also maintained an Outperform rating with a price target of $1,100, expressing confidence in Eli Lilly’s oral GLP-1 medication. Meanwhile, Eli Lilly’s CEO, Dave Ricks, criticized Britain for its drug pricing policies, warning that the country might miss out on new medications without policy changes. These developments highlight Eli Lilly’s ongoing strategic initiatives and the challenges it faces in the global market.

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