Not an
actual patient.

Hypothetical ORSERDU™ (elacestrant) Patient

ORSERDU is a different kind of oral treatment

ORSERDU is a type of hormone therapy called an estrogen receptor antagonist/degrader.


Hormone therapies work by helping to block estrogen from getting to the cells that drive breast cancer growth in patients with ER+ mBC. Without estrogen, the cancer cells may not grow, or grow more slowly. Hormone therapies have been used to treat people with mBC for more than 2 decades.


ORSERDU is different and represents a significant development as the first oral treatment for people with ER+/HER2- ESR1-mutated mBC after progression on endocrine therapy. No other treatment is specifically indicated for ER+/HER2- ESR1-mutated mBC.

Not an actual patient.

Hypothetical ORSERDU™ (elacestrant) Patient

ORSERDU is a different kind of oral treatment

ORSERDU is a type of hormone therapy called an estrogen receptor antagonist/degrader.


Hormone therapies work by helping to block estrogen from getting to the cells that drive breast cancer growth in patients with ER+ mBC. Without estrogen, the cancer cells may not grow, or grow more slowly. Hormone therapies have been used to treat people with mBC for more than 2 decades.


ORSERDU is different and represents a significant development as the first oral treatment for people with ER+/HER2- ESR1-mutated mBC after progression on endocrine therapy. No other treatment is specifically indicated for ER+/HER2- ESR1-mutated mBC.

ORSERDU works better than certain commonly prescribed hormone therapies

Treatment with ORSERDU was evaluated in a 2-year clinical study. The study included a diverse group of people, with 228 people who had ER+/HER2- mBC with an ESR1 mutation whose disease had progressed after prior endocrine therapy.

ORSERDU is proven to help ER+/HER2- ESR1-mutated mBC from spreading, growing, or getting worse

People with mBC lived

2xlonger

without their mBC spreading, growing, or getting worse

The median progression-free survival (mPFS) for people with ESR1-mutated mBC from the start of treatment was 3.8 months for ORSERDU vs 1.9 months for other commonly prescribed hormone therapies

mPFS is a type of time measurement in a clinical trial. It measures the point in time when half of the people in the trial were living without their disease spreading, growing, or getting worse. In the clinical study, ORSERDU was compared with traditional hormone therapies, including fulvestrant, exemestane, anastrozole, and letrozole. No one was given a placebo (sometimes called a sugar pill). These results were achieved with ORSERDU alone, not in combination with any other therapies.

ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; HER2-, human epidermal growth factor receptor 2-negative; mBC, metastatic breast cancer.

Taking ORSERDU

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

ORSERDU may cause serious side effects, including:

  • Increased fat (lipid) levels in your blood (hypercholesterolemia and hypertriglyceridemia). Your healthcare provider will do blood tests to check your lipid levels before and during your treatment with ORSERDU

Before taking ORSERDU, tell your healthcare provider about all your medical conditions, including if you:

  • Have liver problems
  • Are pregnant or plan to become pregnant. ORSERDU can harm your unborn baby

      • Females who are able to become pregnant:

    • Your healthcare provider may do a pregnancy test before you start treatment with ORSERDU
    • You should use effective (contraception) birth control during treatment with ORSERDU and for 1 week after the last dose
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ORSERDU

      • Males with female partners who are able to become pregnant:

    • You should use effective (contraception) birth control during treatment with ORSERDU and for 1 week after the last dose
  • Are breastfeeding or plan to breastfeed. It is not known if ORSERDU passes into your breast milk. Do not breastfeed during treatment with ORSERDU and for 1 week after the last dose

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ORSERDU and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

The most common side effects of ORSERDU include:

  • Muscle and joint (musculoskeletal) pain
  • Nausea
  • Increased cholesterol and triglyceride levels in your blood
  • Increased liver function tests
  • Tiredness
  • Decreased red blood cell counts
  • Vomiting
  • Decreased salt (sodium) levels in your blood
  • Increased kidney function test
  • Decreased appetite
  • Diarrhea
  • Headache
  • Constipation
  • Stomach-area (abdominal) pain
  • Hot flush
  • Indigestion or heartburn

Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with ORSERDU, if you develop certain side effects.

ORSERDU may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of ORSERDU. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

INDICATION

ORSERDU (elacestrant), 345 mg tablets, is a prescription medicine to treat women who have gone through menopause and adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has progressed after endocrine therapy.

Your healthcare provider will perform a test to make sure that ORSERDU is right for you.

It is not known if ORSERDU is safe and effective in children.

Please see full Prescribing Information, including Patient Information.