The 1 for me can offer more time without disease progression
ORSERDU works specifically against ESR1-mutated metastatic breast cancer. It helped people live 2x longer without their disease spreading, growing, or getting worse.
The median progression-free survival (mPFS) for people with ESR1-mutated cancer from the start of treatment was 3.8 months for ORSERDU vs 1.9 months for other commonly prescribed hormone therapies. Individual results may vary.
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.
less risk of disease progression with ORSERDU
In the clinical study, people who took ORSERDU had a 45% reduction in the risk of their cancer growing, spreading, or getting worse when compared to people who took other hormone therapies.
less risk of disease progression with ORSERDU
In the clinical study, people who took ORSERDU had a 45% reduction in the risk of their cancer growing, spreading, or getting worse when compared to people who took other hormone therapies.
ORSERDU works better than certain common hormone therapies
ORSERDU was compared with common hormone therapies such as exemestane, anastrozole, letrozole, and fulvestrant. No one was given a placebo (sometimes called a sugar pill).
ORSERDU was studied:
over 2 years
in 228 patients
to see if it would stop or slow progression in ESR1-mutated, ER+/HER2- advanced or metastatic breast cancer. When cancer progresses, it spreads, grows, or gets worse.
In the clinical study:
- All people had previously taken a type of treatment called a CDK4/6 inhibitor. These included treatments such as Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib)
- ORSERDU was given alone. It was not given in combination with any other therapies
Ibrance is a registered trademark of Pfizer Inc. Kisqali is a registered trademark of Novartis AG. Verzenio is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
CDK4/6, cyclin-dependent kinase 4/6; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; HER2-, human epidermal growth factor receptor 2-negative.
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
- 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
- You should use effective (contraception) birth control during treatment with ORSERDU and for 1 week after the last dose
Females who are able to become pregnant:
Males with female partners who are able to become pregnant:
- 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.
ORSERDU is available as 345 mg tablets and 86 mg tablets.
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) 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, for ORSERDU.