New breast cancer drug wins FDA approval after slashing progression risk by nearly 40%

The U.S. Food and Drug Administration has approved a new treatment for advanced breast cancer.

Drugmaker Eli Lilly announced on Sept. 25 the approval of Inluriyo, an oral estrogen receptor antagonist, to treat adults with specific types of the disease.

Those types include estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer.

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The once-daily pill is also meant for those who saw disease progression after at least one line of endocrine (hormone) therapy, according to a press release.

In the phase 3 EMBER-3 trial, Inluriyo reportedly reduced the risk of cancer progression or death by 38% compared to endocrine therapy.

Patients with ESR1-mutated metastatic breast cancer saw a “significant” improvement in progression-free survival with Inluriyo, compared to other hormone treatments like fulvestrant or exemestane, with a median survival of 5.5 months versus 3.8 months.

Function and side effects

Some cancers develop mutations that can cause estrogen receptors to “become overactive and drive cancer growth,” Eli Lilly noted.

Inluriyo works to bind, block and facilitate the “degradation of these receptors,” which helps to slow the disease progression.

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“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,” study lead Komal Jhaveri, M.D., section head of endocrine therapy research and clinical director of early drug development at Memorial Sloan Kettering Cancer Center, commented in a press release statement.

“With its demonstrated efficacy, tolerability profile and oral administration, this therapy provides a meaningful alternative treatment option for this patient population.”

Inluriyo comes with a warning that it may be dangerous for an unborn baby, which means women who are pregnant or could become pregnant should talk to their doctor before taking it.

During the phase 3 trial, common side effects were “low grade” but included lab abnormalities, musculoskeletal pain, fatigue, diarrhea, nausea, constipation, abdominal pain, an increase in cholesterol and triglycerides, and a reduction in hemoglobin, calcium, platelets, white blood cells and certain enzymes mostly found in the liver, per the FDA.

“It’s critical to ensure patients receive informed, individualized guidance.”

Around 4.6% of patients discontinued treatment due to these adverse events, while 2.4% reduced their doses and 10% had dose interruptions.

‘Hopeful but vigilant’

Jacob Van Naarden, executive vice president and president of Lilly Oncology in Indianapolis, commented that 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.”

“This therapy has the potential to make the treatment journey more manageable for those living with breast cancer.”

Eli Lilly shared that Inluriyo will continue to be studied in the ongoing phase 3 EMBER-4 trial for patients with ER+, HER2– early breast cancer at an increased recurrence risk. This trial will enroll about 8,000 patients globally.

Inluriyo is expected to be available in the U.S. in “the coming weeks,” according to the company.

Fox News medical contributor Dr. Nicole Saphier, radiologist and director of breast imaging at Memorial Sloan Kettering Cancer Center in New York, reacted to the drug approval in an interview with Fox News Digital.

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“In approving this new medication, the FDA has granted patients who develop resistance to first-line therapies with a new, evidence-based option — one that showed a 38% reduction in risk of progression or death in the EMBER-3 trial,” she said.

“Just this morning, I saw a woman whose cancer persists because of this exact ESR1 mutation, and breakthroughs like this are changing the landscape — delivering more selective treatments and giving people who once felt hopeless, hope.”

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Saphier added that it’s “critical to remain vigilant” about potential safety issues with this treatment, including fatal cardiovascular events — “and to ensure that patients receive informed, individualized guidance.”