What You'll Learn
- Who this drug is approved for
- How well it worked in clinical trials
- What side effects to watch for
- Who was studied and what they had in common
- A preliminary finding about cancer spreading to the brain
The FDA Approved This Drug Based on One Study
The FDA approved Inluriyo in 2025 for adults with a specific type of breast cancer. To qualify, your cancer must:
- Be driven by the hormone estrogen, often called “hormone receptor positive” or “HR-positive” breast cancer
- Not have a protein called HER2, often called “HER2-negative” breast cancer
- Have a gene change called ESR1, which can make some hormone treatments stop working
- Have kept growing even after at least one hormone-based treatment
The approval came from a study called EMBER-3, which included people who had already tried a hormone treatment called an aromatase inhibitor.
What does this mean? It means that if you have HR-positive, HER2-negative breast cancer with the ESR1 gene change, and your cancer has continued to grow even while taking a hormone-based treatment, Inluriyo may be another option for you.
Cancer Took Longer to Grow With Inluriyo
In the EMBER-3 study, people who took Inluriyo went a median of 5.5 months before their cancer started growing again. That means half of the people went longer than 5.5 months, and half went less. People on standard hormone treatment only went a median 3.8 months.
What does this mean? People taking Inluriyo may go almost 2 months longer before their cancer starts to regrow compared to people taking standard hormone treatment.
Adding a Second Medicine Made It Work Even Better
When patients took Inluriyo together with another cancer drug called abemaciclib (Verzenio), they went a median of 9.4 months without their cancer growing, compared to 5.5 months with Inluriyo alone.
What does this mean? People taking Inluriyo + Verzenio may go about 5.6 months longer before their cancer starts to regrow compared to people taking standard hormone treatment.
Patients Lived Longer Overall
In a longer follow-up of the same study, people who took Inluriyo lived a median of 34.5 months (nearly 3 years). People on standard hormone treatment lived a median of 23.1 months (just under 2 years).
What does this mean? People taking Inluriyo may live more than a year longer compared to people taking standard hormone treatment.
Tiredness and Diarrhea Were the Most Common Side Effects
Like most cancer medicines, Inluriyo can cause side effects. The most common ones were:
Most of these were mild.
What does this mean? You should talk to your care team if any side effects are bothering you. They can often help.
Some Patients Had More Serious Side Effects
A small number of patients had more serious problems:
- Anemia (low red blood cells), which makes you feel tired or weak
- Neutropenia (low white blood cells), which makes it harder for your body to fight infections
Each of these happened in about 1 out of 50 patients, which was similar to rates seen with standard treatment.
What does this mean? Your care team will check your blood regularly and may change your treatment if needed.
Who Was in the Study?
All patients with the ESR1 gene change were female, with a typical age of about 61 years old. More than half had cancer that had spread to organs inside the body, and about 60% had already tried another type of targeted treatment.
What does this mean? The study results are most relevant to people with breast cancer similar to those in the study.
Inluriyo May Help Keep Cancer From Spreading to the Brain
One promising finding: Inluriyo appears to cross the blood-brain barrier, a natural filter that protects the brain and that many medicines cannot get through.
In the study, cancer spread to the brain in only 1.5% of Inluriyo patients, compared to 6.7% on standard treatment.
What does this mean? This finding is encouraging, but more research is still needed because the number of affected patients was small, more research is still needed.
