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Emrelis

telisotuzumab vedotin
c-Met Directed ADCFDA Approved 2025AbbVie
Route
IV
Half-Life
~7 days
FDA Approved
2025
Manufacturer
AbbVie
1. Indications and Usage

Adults with locally advanced or metastatic nonsquamous NSCLC with high c-Met protein overexpression who have received prior systemic therapy.

2. Dosage and Administration

1.9 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity.

3. Dosage Forms and Strengths

Injection: 340 mg lyophilized powder in single-dose vial

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Ocular Toxicity: Conduct ophthalmic exams at baseline and regularly during treatment.
  • Peripheral Neuropathy: Monitor; consider dose delay, reduction, or discontinuation.
  • ILD/Pneumonitis: Fatal cases reported. Monitor and permanently discontinue if confirmed.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Peripheral Neuropathy (42%), Ocular Toxicity (40%), Nausea (36%), Fatigue (32%), Musculoskeletal Pain (26%), Decreased Appetite (24%), Peripheral Edema (20%), Alopecia (18%)

Peripheral Neuropathy
42%
Ocular Toxicity
40%
Nausea
36%
Fatigue
32%
Musculoskeletal Pain
26%
Decreased Appetite
24%
Peripheral Edema
20%
Alopecia
18%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inhibitors: Monitor for increased adverse reactions from the MMAE component.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Telisotuzumab vedotin is an ADC comprising a c-Met-directed monoclonal antibody conjugated to MMAE. Upon binding c-Met on tumor cells, it is internalized and releases MMAE, disrupting microtubules and inducing apoptosis.

Pharmacokinetics

Half-life (ADC): ~3-4 days. Half-life (MMAE): ~3 days. Clearance: 0.7 L/day.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
FDA-Approved Tumor Types

Emrelis has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

External Resources
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Emrelis. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Emrelis (telisotuzumab vedotin) approved for?

Emrelis (telisotuzumab vedotin) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Emrelis (telisotuzumab vedotin) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Emrelis (telisotuzumab vedotin) work?

Telisotuzumab vedotin is an ADC comprising a c-Met-directed monoclonal antibody conjugated to MMAE. Upon binding c-Met on tumor cells, it is internalized and releases MMAE, disrupting microtubules and inducing apoptosis.

What are the most common side effects?

Peripheral Neuropathy (42%), Ocular Toxicity (40%), Nausea (36%), Fatigue (32%), Musculoskeletal Pain (26%), Decreased Appetite (24%), Peripheral Edema (20%), Alopecia (18%) Peripheral Neuropathy 42% Ocular Toxicity 40% Nausea 36% Fatigue 32% Musculoskeletal Pain 26% Decreased Appetite 24% Periphera