Brand Name
Emrelis
Generic Name
Telisotuzumab Vedotin
View Brand Information FDA approval date: May 14, 2025
Form: Injection
What is Emrelis (Telisotuzumab Vedotin)?
EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression [≥50% of tumor cells with strong staining], as determined by an FDA-approved test [see Dosage and Administration.
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A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
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Brand Information
EMRELIS (Telisotuzumab Vedotin)
1INDICATIONS AND USAGE
EMRELIS is indicated 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 [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response
2DOSAGE FORMS AND STRENGTHS
For injection: 20 mg or 100 mg of telisotuzumab vedotin-tllv as a white to off-white, lyophilized powder in a single-dose vial for reconstitution and further dilution.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Peripheral Neuropathy
- Interstitial Lung Disease (ILD)/Pneumonitis
- Ocular Surface Disorders
- Infusion-Related Reactions (IRR)
4.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
LUMINOSITY
The safety population described in
The median age of patients who received EMRELIS was 64.5 years (range: 33 to 83 years); 70% were male; 65% were White; 1.8% were Black or African American, 33% were Asian; and 0.6% were of Hispanic or Latino ethnicity.
Serious adverse reactions occurred in 35% of patients. Serious adverse reactions occurring in ≥2% of patients included ILD/pneumonitis (5%), pneumonia (5%), peripheral neuropathy (3.6%), and pleural effusion (2.4%). Fatal adverse reactions occurred in 5% of patients who received EMRELIS, including ILD/pneumonitis (1.8%), pneumonia (1.2%), sudden death (1.2%), noninfectious endocarditis (0.6%) and myocardial infarction (0.6%).
Permanent discontinuations of EMRELIS due to adverse reactions occurred in 30% of patients. Adverse reactions which resulted in permanent discontinuation of EMRELIS in ≥2% included peripheral neuropathy and ILD/pneumonitis.
Dosage interruptions due to adverse reactions occurred in 44% of patients. Adverse reactions which required dosage interruption in ≥2% of patients included peripheral neuropathy, fatigue, pneumonia, increased ALT, blurred vision, COVID-19, ILD/pneumonitis, and keratitis.
Dose reductions due to adverse reactions occurred in 28% of patients. Adverse reactions which required dose reductions in ≥2% of patients included peripheral neuropathy, fatigue, and keratitis.
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 ALT, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium.
Table 5 summarizes the adverse reactions in LUMINOSITY.
Other clinically relevant adverse reactions in <10% of patients who received EMRELIS included arthralgia,
Table 6 presents laboratory abnormalities in LUMINOSITY.
Percentages were calculated using patients with worsening laboratory values from baseline and the number of patients with both baseline and post-treatment measurements as the denominator.
5DESCRIPTION
Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa.
EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, white to off-white, preservative-free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. EMRELIS is supplied as 20 mg per vial or 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL and 5.2 mL, respectively) to obtain a concentration of 20 mg/mL
6CLINICAL STUDIES
Previously Treated EGFR Wild-Type Non-squamous NSCLC with Highc-Met Protein Overexpression
LUMINOSITY
The efficacy of EMRELIS was evaluated in the LUMINOSITY study (NCT03539536), a multicenter, open-label, single-arm, multi-cohort clinical trial. Eligible patients were required to have locally advanced or metastatic NSCLC with c-Met protein overexpression and treatment with prior systemic therapy (including no more than one line of prior chemotherapy) in the locally advanced or metastatic setting. The study excluded patients who had received radiation therapy to the lungs <6 months prior to enrollment and patients who had a history of ILD/pneumonitis requiring treatment with steroids or ILD/pneumonitis within 3 months of the first dose.
Patients received EMRELIS at 1.9 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity. The major efficacy outcome measure was overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by a blinded independent central review (BICR). An additional efficacy outcome measure was duration of response (DOR) by BICR.
The efficacy population included 84 patients with non-squamous, EGFR wild-type NSCLC with high c-Met protein overexpression who had received prior systemic therapy. High c-Met protein overexpression was defined as ≥50% of tumor cells with strong (3+) membrane staining on archival or recent tissue samples by immunohistochemistry (IHC) and was determined by prospective testing at a central laboratory prior to enrollment using the MET (SP44) clinical trial assay (CTA). Of the 84 patients with high c-Met protein overexpression identified by central testing using the CTA, tissue samples from 38/84 (45%) patients were tested retrospectively using the VENTANA MET (SP44) RxDx assay. One sample was unevaluable. Of the 37 samples retested and evaluable, 32 (87%) samples were confirmed to have high c-Met protein overexpression, defined as ≥50% of tumor cells with strong (3+) membrane and/or cytoplasmic staining.
The median age was 64 years (range: 38 to 83 years); 75% were male; 61% were White, 1.2% were Black or African American, 38% were Asian; none were of Hispanic or Latino ethnicity. Twenty-five percent had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 and 74% had ECOG PS of 1; 19% were never smokers, 68% were former smokers, and 13% were current smokers; 99% had Stage IV disease; and 19% of patients had previously treated brain metastases. The median number of lines of prior therapies was 1 (range 1 - 3); 73% of patients had one line, 24% had two lines, and 3.6% had three lines of prior systemic therapy; 96% of patients had prior platinum therapy, 82% had prior immunotherapy (anti-PD-1/PD-L1), 6% had prior targeted therapy, and 3.6% had prior MET tyrosine kinase inhibitor therapy.
Efficacy results are summarized in Table 8.
7REFERENCES
1. "OSHA Hazardous Drugs."
8HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, preservative-free, white to off-white lyophilized powder, supplied in a glass single-dose vial.
- Carton of one 20 mg/vial (NDC 0074-1044-01)
- Carton of one 100 mg/vial (NDC 0074-1055-01)
Storage and Handling
Store refrigerated at 2
Special Handling
EMRELIS is a hazardous product. Follow special handling and disposal procedures.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Peripheral Neuropathy
Advise patients that EMRELIS can cause peripheral neuropathy. Advise patients to report to their healthcare provider any new or worsening numbness or tingling of the hands or feet or any muscle weakness
ILD/Pneumonitis
Advise patients that EMRELIS can cause ILD/pneumonitis. Advise patients to immediately report to their healthcare provider any new or worsening respiratory symptoms
Ocular Surface Disorders
Advise patients that EMRELIS can cause ocular surface disorders. Advise patients to contact their healthcare provider any new or worsening ocular problems or vision changes
Infusion-Related Reactions
Advise patients that EMRELIS can cause infusion-related reactions. Advise patients to immediately contact their healthcare provider if they experience signs and symptoms of infusion reactions, including fever, chills, rash, or breathing problems
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise female patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with EMRELIS
Females and Males of Reproductive Potential
- Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose
- Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose
Lactation
Advise women not to breastfeed during treatment with EMRELIS and for 1 month after the last dose
Infertility
Advise males and females of reproductive potential that EMRELIS may impair fertility
EMRELIS™ [telisotuzumab vedotin-tllv]
Manufactured by:
20090524
10PRINCIPAL DISPLAY PANEL
NDC 0074-1044-01
Emrelis™
(telisotuzumab vedotin-tllv)
For Injection
20 mg per vial
Hazardous Drug
For Intravenous Infusion after reconstitution
and dilution
Single-Dose Vial
Discard Unused Portion
Dispense the enclosed Medication Guide to
each patient
Rx Only
abbvie
11PRINCIPAL DISPLAY PANEL
NDC 0074-1055-01
Emrelis™
(telisotuzumab vedotin-tllv)
For Injection
100 mg per vial
Hazardous Drug
For Intravenous Infusion after reconstitution
and dilution
Single-Dose Vial
Discard Unused Portion
Dispense the enclosed Medication Guide to
each patient
Rx Only
abbvie
