EMRELIS is a prescription medicine used to treat adults with non-squamous non-small cell lung cancer (NSCLC) that has spread to areas near the lungs or to other parts of the body, and whose tumors have high c-Met protein overexpression,* and who received a prior treatment. Your healthcare provider will perform a test to make sure EMRELIS is right for you.
The first and only treatment for people with a newly identified biomarker called high c-Met protein overexpression*
ABOUT EMRELIS
EMRELIS is approved based on response rate and how long patients’ responses lasted. A study is ongoing to confirm the clinical benefit of EMRELIS.
Click here to learn how EMRELIS works. It is not known if EMRELIS is safe and effective in children.
c-Met protein overexpression is a type of MET aberration where there is an excess of the c-Met protein on the surface of cells.
IHC is an established testing method in NSCLC. MET IHC test is the one available to determine if a patient has high c-Met protein overexpression.
Talk to your doctor about testing for high c-Met protein overexpression to help determine if treatment with EMRELIS may be right for you.
*High c-Met protein overexpression is determined by an immunohistochemistry (IHC) test and defined as ≥50% of tumor cells with strong (3+) staining.
RESULTS
How EMRELIS performed in a clinical trial
EMRELIS was studied in the LUMINOSITY clinical trial with 84 adults who were previously treated for late-stage non-squamous NSCLC with high c-Met protein overexpression.*
Partial
Response: 35%
Complete
Response: 0%
Overall response: 35% saw tumors shrink
Overall response is a measure of all people who had either a complete or partial response.
Out of the 84 people treated with EMRELIS, 29 people achieved a partial response, meaning a reduction in tumor size or presence by at least 30%.
A complete response is defined as the patient having no signs of cancer on a follow-up scan. No one had a complete response.
Duration of response:Of the 29 people who responded to EMRELIS, the decrease in their tumor size lasted for a median† of 7.2 months.
Of the 29 people who responded to EMRELIS:
- 59%, or 17 responders, had their response last 6 months or longer
- 21%, or 6 responders, had their response last 12 months or longer
Your results with EMRELIS may vary. Talk to your healthcare team if you have questions.
*High c-Met protein overexpression is determined by an immunohistochemistry (IHC) test and defined as ≥50% of tumor cells with strong (3+) staining.
†Middle value in the entire set of response times.
SIDE EFFECTS
What is the most important information I should know about EMRELIS?
EMRELIS can cause serious side effects, including:
- Nerve problems in your hands or feet (peripheral neuropathy). Nerve problems are common during treatment with EMRELIS and can also be severe. Tell your healthcare provider if you develop any new or worsening signs or symptoms of nerve problems, including:
- numbness
- tingling
- burning sensation
- pain or discomfort
- muscle weakness
- difficulty walking
- Lung problems. EMRELIS can cause lung problems that may be severe, life-threatening or that may lead to death. Tell your healthcare provider right away if you develop new or worsening lung symptoms, including:
- cough
- trouble breathing or shortness of breath
- fever
- wheezing
- Eye problems. Your healthcare provider may send you to an eye care professional to check your eyes if you develop eye problems. Tell your healthcare provider right away if you develop any new or worsening eye problems or vision changes, including:
- blurred vision
- dry eyes
- sensitivity to light
- eye pain or swelling
- eye redness
- Infusion-related reactions. EMRELIS can cause infusion reactions that can be severe or life-threatening. Tell your healthcare provider right away if you develop any signs and symptoms of infusion reactions, including:
- itching or rash
- shortness of breath or wheezing
- flushing
- chest discomfort
- fever
- back pain
- chills
- headache
- nausea or vomiting
- feel like passing out
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with EMRELIS and may provide treatment for your side effects. Your healthcare provider may also need to change your dose, temporarily stop, or completely stop treatment with EMRELIS if you have severe side effects.
What are the possible side effects of EMRELIS?
EMRELIS can cause serious side effects. See “What is the most important information I should know about EMRELIS?”
The most common side effects of EMRELIS include:
- feeling tired
- decreased appetite
- swelling in the feet, ankles, legs or hands
The most common severe abnormal laboratory test results with EMRELIS include:
- decreased white blood cell counts
- increased blood sugar levels
- increased blood liver enzyme levels
- decreased blood phosphorus levels
- decreased blood sodium levels
- decreased red blood cell counts
- decreased blood calcium levels
EMRELIS may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of EMRELIS.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
HOW IT WORKS
How EMRELIS works
EMRELIS works by targeting c-Met protein.
EMRELIS contains the active substance telisotuzumab vedotin which is made up of a protein referred to as a monoclonal antibody which is linked to a substance called MMAE (monomethyl auristatin E) that can disrupt cell growth and trigger cell death. The monoclonal antibody recognizes cells with increased amounts of c-Met protein and delivers the MMAE to the cells.
Normal Cell
c-Met protein is normally present at low levels on certain cells.
Cancer Cell
In certain cancers like NSCLC, tumor cells may have c-Met protein overexpression, which can cause those cells to not only survive but grow and rapidly spread.
EMRELIS
EMRELIS targets and binds to c-Met receptors on the cell’s surface. It then enters the cell and releases a potent medicine, disrupting cell growth and triggering cell death.
EMRELIS can also harm normal cells.
Illustrative purposes only.
TAKING EMRELIS
Before receiving EMRELIS, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of nerve problems
- have lung or breathing problems other than your lung cancer
- have eye problems
- have liver problems
- are pregnant or plan to become pregnant. EMRELIS can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with EMRELIS.
- You should use effective birth control (contraception) during treatment and for 2 months after your last dose of EMRELIS.
- Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EMRELIS.
Males with female partners who are able to become pregnant:
- You should use an effective birth control during treatment and for 4 months after your last dose of EMRELIS.
- are breastfeeding or plan to breastfeed. It is not known if EMRELIS passes into your breast milk. Do not breastfeed during treatment with EMRELIS and for 1 month 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. Taking certain medicines with EMRELIS may increase your risk of side effects.
How will I receive EMRELIS?
- Your healthcare provider will give you EMRELIS into your vein through an intravenous (IV) line over 30 minutes.
- EMRELIS is given 1 time every 2 weeks.
- Your healthcare provider will decide how many infusions of EMRELIS you will receive.
IHC=immunohistochemistry; NSCLC=non-small cell lung cancer.
PATIENT SUPPORT
EMRELIS Support Services
EMRELIS Support Services is here to help you and your provider navigate your treatment journey.
Your provider can work directly with EMRELIS Support Services to understand your insurance coverage for EMRELIS and determine co-pay assistance eligibility.
Commercially insured patients could pay as little as $0 for their medication‡
Your provider can help you enroll in EMRELIS Support Services to receive co-pay assistance. Make sure you ask your provider to help you enroll. Once enrolled, you won’t need to do anything to receive this assistance.
MyAbbVie Assist
If you are having difficulty paying for your medicine, AbbVie may be able to help.
Visit AbbVie.com/PatientAccessSupport to learn more.
‡ Terms and Conditions apply. This benefit covers EMRELIS (telisotuzumab vedotin-tllv). Eligibility: Available only to patients with commercial insurance coverage for EMRELIS who meet eligibility criteria. The form of co-pay assistance, enrollment requirements, and processes may vary. Please call 1-844-859-5760 for additional information. Co-pay assistance program is not available to patients receiving reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If you live or receive treatment in certain states, you may not be eligible. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the EMRELIS Savings Card and patient must call 1-844-859-5760 to stop participation. Co-pay assistance provided under this program may not be transferred to or utilized for the benefit of third parties, including, without limitation, third-party insurance plans and/or pharmacy benefit managers and their agents. By enrolling in the co-pay assistance program, you agree that this program is intended solely for the benefit of you, the patient. Some health plans have established programs referred to as “accumulator adjustment” or “co-pay maximizer” programs. An accumulator adjustment program is one in which payments made by you that are subsidized by manufacturer assistance do not count toward your deductibles and other out-of-pocket cost sharing limitations. Co-pay maximizers are programs in which the amount of your out-of-pocket costs is increased to reflect the availability of support offered by a manufacturer assistance program. Except where prohibited by applicable state law, if your insurance company or health plan implements either an accumulator adjustment or co-pay maximizer program, you will not be eligible for, and agree not to use, co-pay assistance because these programs are inconsistent with our agreed intent that this program is solely for your benefit. You also agree that you are personally responsible for paying any amount of co-pay required after the savings card is applied. Any out-of-pocket costs remaining after the application of the savings card may not be paid by your health plan, pharmacy benefit programs, or any other program. If you learn your insurance company or health plan has implemented either an accumulator adjustment program or a co-pay maximizer program, you agree to inform AbbVie of this fact by calling 1-844-859-5760 to discuss alternative options that may be available to support you. You also agree that you are personally responsible for paying any amount of co-pay required after the savings card is applied. Any out-of-pocket costs remaining after the application of the savings card may not be paid by your health plan, pharmacy benefit programs, or any other program. Subject to all other terms and conditions, the maximum annual benefit that may be available solely for the patient’s benefit under the co-pay assistance program is $25,000 per calendar year. The actual application and use of the benefit available under the co-pay assistance program may vary on a monthly, quarterly, and/or annual basis depending on each individual patient’s plan of insurance and other prescription drug costs. This co-pay assistance program is subject to change, reduction in monetary amount, or discontinuation without any notice. AbbVie in its sole discretion may unilaterally reduce or discontinue the maximum annual benefit for any reason. Except where prohibited by applicable law, this includes potential reduction or discontinuation to ensure that co-pay assistance is utilized solely for the patient’s benefit. Patients may not seek reimbursement for value received from the EMRELIS Savings Card Program from any third-party payers, including insurance plans, flexible spending plans or health savings accounts. Co-pay support made available under this program may not be used with any other coupon, discount, prescription savings card, free trial, or other offer (including any program offered by a third-party insurance plan or pharmacy benefit manager, or an agent of either, that adjusts patient cost-sharing obligations). Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This assistance offer is not health insurance. The failure to enforce any provision of these Terms and Conditions does not constitute a waiver by AbbVie of that or any other provision. By utilizing this co-pay assistance program, you hereby accept and agree to abide by these terms and conditions. Any individual or entity who enrolls or assists in the enrollment of a patient in the co-pay assistance program represents that the patient meets the eligibility criteria and other requirements described herein. Further, you agree that you currently meet the eligibility criteria and other requirements described herein every time you use the co-pay assistance program. To learn about AbbVie’s privacy practices and your privacy choices, visit https://abbv.ie/corpprivacy.
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