On May 14, 2025 AbbVie (NYSE: ABBV) reported that EMRELIS (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy (Press release, AbbVie, MAY 14, 2025, View Source [SID1234653092]). High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test.2,3
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This indication is approved based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody-drug conjugate (ADC) and the first and only treatment approved for this patient population. ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent ‘payload’ directly to the biomarker-expressing cell.
Approximately 85% of lung cancers are classified as NSCLC4,5 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world.1 The c-Met protein is found to be overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients and is associated with poor prognosis.2,6-12 Approximately half of these patients have high c-Met overexpression, defined as ≥ 50% of tumor cells with strong (3+) staining by immunohistochemistry (IHC) test.2
"We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes," said Jonathan Goldman, MD, professor of medicine, director of thoracic oncology clinical trials, UCLA. "People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and EMRELIS is a first-in-class ADC that can address a critical unmet need for this patient population."
"EMRELIS, AbbVie’s first internally developed solid tumor medicine and our first solid tumor FDA approval in lung cancer, is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease," said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie. "Leveraging advanced technology and data science, we are growing our ADC portfolio designed to deliver the right medicines to the right patients in need across a range of difficult-to-treat tumors."
"Despite the progress we have seen in the treatment of lung cancer, we need more options for people whose treatments stop working," said Upal Basu Roy, PhD, MPH, executive director of research, LUNGevity Foundation, a leading lung cancer nonprofit organization. "This approval is a welcomed targeted therapy for those with high c-Met protein overexpressing late-stage, non-small cell lung cancer who have seen very limited treatment innovation in the last decade."
The FDA accelerated approval is supported by data from the Phase 2 LUMINOSITY study (NCT03539536), a study designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations. Findings from the study showed patients with high c-Met protein overexpression (n=84) who received EMRELIS demonstrated a 35% (95% CI: 24, 46) Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months (95% CI: 4.2, 12). The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite and peripheral edema. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium.2
In December 2021, the FDA granted EMRELIS Breakthrough Therapy Designation (BTD) based on Phase 2 LUMINOSITY study data.
EMRELIS is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites. Additional information on clinical trials for EMRELIS is available at www.clinicaltrials.gov.
The FDA has also approved the Roche VENTANA MET (SP44) RxDx Assay, the only IHC companion diagnostic that identifies patients eligible for treatment with EMRELIS. To determine c-Met protein biomarker status, patients can be tested on recent or archived tissue.
About the LUMINOSITY Trial
The LUMINOSITY trial (NCT03539536) is an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for telisotuzumab vedotin-tllv monotherapy in the second-line or third-line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The endpoints include overall response rate (ORR), duration of response (DOR), disease control rate (DCR) and progression-free survival (PFS) per independent central review (ICR) as well as overall survival (OS).2
Patient Access and Support
AbbVie is committed to helping people access EMRELIS and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $0 per month for eligible, commercially insured patients. Financial support might also include reimbursement for out-of-pocket costs related to IV administration. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides EMRELIS at no charge to those who qualify. More information can be found at www.AbbVie.com/PatientAccessSupport.
About EMRELIS
EMRELIS (telisotuzumab vedotin-tllv) is a first-in-class c-Met-directed antibody-drug conjugate (ADC) comprising of a c-Met-binding antibody, cleavable linker and the monomethyl auristatin E (MMAE) payload designed to target c-Met expressing cells.3 The c-Met protein is a receptor tyrosine kinase that can be overexpressed in NSCLC and is associated with poor prognosis.2, 6-12
EMRELIS (telisotuzumab vedotin-tllv) U.S. Uses and Important Safety Information3
What is EMRELIS?
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 (locally advanced) or to other parts of the body (metastatic), and
whose tumors have high c-Met protein overexpression, and
who have received a prior treatment.
Your healthcare provider will perform a test to make sure EMRELIS is right for you.
It is not known if EMRELIS is safe and effective in children.
IMPORTANT SAFETY INFORMATION
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.
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 taking the 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.
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 tests results of 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.
Please see the Full Prescribing Information and Medication Guide.