U.S. FDA Approves EMRELIS™ (telisotuzumab vedotin-tllv) for Adults With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) With High c-Met Protein Overexpression

Rhea-AI Summary

The FDA has granted accelerated approval to AbbVie's EMRELIS™ (telisotuzumab vedotin-tllv) for treating adult patients with advanced non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received prior therapy. EMRELIS, an antibody-drug conjugate (ADC), is the first and only treatment approved for this specific patient population. The approval is based on the Phase 2 LUMINOSITY study results, which showed a 35% Overall Response Rate and a median Duration of Response of 7.2 months. The c-Met protein is overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients, with about half having high c-Met overexpression. The FDA also approved the Roche VENTANA® MET (SP44) RxDx Assay as a companion diagnostic.

Positive

• First-in-class treatment approved for previously untreatable patient population
• Strong efficacy with 35% Overall Response Rate in Phase 2 LUMINOSITY study
• Breakthrough Therapy Designation granted by FDA
• Represents AbbVie's first internally developed solid tumor medicine and first FDA approval in lung cancer
• Companion diagnostic test approved alongside the treatment for patient identification

Negative

• Approval is accelerated and contingent upon confirmatory trial results
• Significant adverse reactions reported including peripheral neuropathy and fatigue
• Limited duration of response with median of 7.2 months
• Multiple Grade 3 or 4 laboratory abnormalities observed in patients

Insights

Oncology Specialist

FDA's approval of EMRELIS offers new hope for previously treated NSCLC patients with high c-Met overexpression, addressing a significant unmet need.

The FDA's accelerated approval of EMRELIS (telisotuzumab vedotin-tllv) represents a significant breakthrough in targeted therapy for non-small cell lung cancer (NSCLC). This antibody-drug conjugate (ADC) is specifically designed to target tumors with high c-Met protein overexpression, which occurs in approximately 12.5% of advanced EGFR wild type, non-squamous NSCLC patients. These patients typically face poor prognosis and have had limited treatment options until now.

The approval is based on compelling efficacy data from the Phase 2 LUMINOSITY study, which demonstrated an overall response rate of 35% and a median duration of response of 7.2 months. For context, these response rates are meaningful in a previously treated population where response rates to standard therapies often fall below 20%.

EMRELIS works through a precision medicine approach - it's an antibody-drug conjugate that specifically targets the c-Met protein on cancer cells and delivers a cytotoxic payload directly to those cells. This mechanism allows for more targeted treatment with potentially reduced systemic toxicity compared to traditional chemotherapy.

However, it's important to note this is an accelerated approval contingent upon confirmatory trial results. The ongoing Phase 3 TeliMET NSCLC-01 study will be crucial to verify clinical benefit. The safety profile shows typical ADC-associated toxicities including peripheral neuropathy, which will require monitoring in clinical practice.

This approval represents significant progress in biomarker-driven therapy for NSCLC, allowing for better patient selection through companion diagnostic testing with the VENTANA® MET (SP44) RxDx Assay. For AbbVie, this marks their entry into the solid tumor space in lung cancer, expanding beyond their traditional therapeutic areas.

–        EMRELIS is the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression who often face poor prognosis and have limited treatment options
–        Lung cancer remains the leading cause of cancer-related deaths throughout the world¹

NORTH CHICAGO, Ill., May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced 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. 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

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 NSCLC^4,5 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.

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), Immuno-Oncology-based therapeutics, multi-specific antibody and in situ CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.

Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. 

AbbVie Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

Disclosure: Johnathan Goldman, MD has financial interests related to AbbVie.

References

1. American Cancer Society. Key statistics for lung cancer. 2025. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed May 2, 2025.
2. Camidge DR, et al. Telisotuzumab Vedotin monotherapy in patients with previously treated c-Met protein-overexpressing advanced nonsquamous EGFR-wildtype non-small cell lung cancer in the Phase II LUMINOSITY trial. J Clin Oncol. 2024 Sep 1;42(25):3000-3011. doi: 10.1200/JCO.24.00720. Epub 2024 Jun 6. PMID: 38843488; PMCID: PMC11361350.
3. EMRELIS [package insert]. North Chicago, IL: AbbVie Inc: 2025.
4. National Cancer Institute. Non-small cell lung cancer treatment – health professional version. https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_37_toc. Accessed May 2, 2025.
5. American Cancer Society. Cancer facts & figures 2025. American Cancer Society; 2025. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Accessed May 2, 2025.
6. Bar, J. et al. 1397P Prevalence, molecular characterization, and prognosis of MET–overexpressing non-small cell lung cancer (NSCLC) in a real-world patient cohort. Ann Oncol, Volume 34, S799 - S800.
7. Le X, Aggarwal C, Simmons A, et al. METPRO: Evaluating prognostic value of c-Met protein overexpression and concurrent biomarker presence. Ann Oncol. 2024;35(S2):S829.
8. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 2024;74(3):229-63.
9. Ansell PJ, Baijal S, Liede A, et al. Prevalence and characterization of c-Met–overexpressing non-small cell lung cancer (NSCLC) across clinical trial samples and real-world patient cohorts from the City of Hope National Medical Center. Cancer Research UK (CRUK) - Lung Cancer Conference; Manchester, UK2022.
10. Liang H, Wang M. MET Oncogene in non-small cell lung cancer: Mechanism of MET dysregulation and agents targeting the HGF/c-Met Axis. Onco Targets Ther. 2020;13:2491-510.
11. Park S, Choi YL, Sung CO, et al. High MET copy number and MET overexpression: poor outcome in non-small cell lung cancer patients. Histol Histopathol. 2012;27(2):197-207.
12. Guo B, Cen H, Tan X, et al. Prognostic value of MET gene copy number and protein expression in patients with surgically resected non-small cell lung cancer: a meta-analysis of published literatures. PLoS One. 2014;9(6):e99399.

U.S. Media: Stephanie Tennessen +1 (224) 214-8638 stephanie.tennessen@abbvie.com

Investors: Liz Shea +1 (847) 935-2211 liz.shea@abbvie.com

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FAQ

What is EMRELIS and what did the FDA approve it for?

EMRELIS is a c-Met-directed antibody-drug conjugate approved by the FDA for treating adult patients with advanced non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received prior therapy. It's the first treatment approved for this specific patient population.

What were the efficacy results of ABBV's EMRELIS in the LUMINOSITY study?

In the Phase 2 LUMINOSITY study, EMRELIS demonstrated a 35% Overall Response Rate and a median Duration of Response of 7.2 months in patients with high c-Met protein overexpression.

What are the main side effects of EMRELIS (ABBV)?

The most common side effects (≥20%) include peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. Several Grade 3 or 4 laboratory abnormalities were also observed.

How many NSCLC patients could potentially benefit from EMRELIS?

Approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients have c-Met protein overexpression, with about half of these having high c-Met overexpression that would make them eligible for EMRELIS treatment.

Is ABBV's EMRELIS approval permanent?

The FDA granted accelerated approval to EMRELIS, which means continued approval is contingent upon verification and description of clinical benefit in confirmatory trials.