Initial US Approval:
2025
Key Clinical Studies:
LUMINOSITY study (NCT03539536)
Drug Class/Description:
A c-Met-directed antibody and microtubule inhibitor conjugate
Indications and Usage:
EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate 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, who have received a prior systemic therapy.
This indication is approved under accelerated approval 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).
Dosage and Administration:
For intravenous infusion only.
- The recommended dosage of EMRELIS is 1.9 mg/kg administered intravenously every 2 weeks until disease progression or unacceptable toxicity.
- Reconstitute and further dilute EMRELIS prior to intravenous infusion.
Dosage Forms and Strengths:
For injection: 20 mg or 100 mg of telisotuzumab vedotin-tllv as a lyophilized powder in a single-dose vial.
Contraindications:
None.
Warnings and Precautions:
- Peripheral Neuropathy: Monitor patients for new or worsening peripheral neuropathy. Withhold, reduce the dose, or permanently discontinue EMRELIS based on the severity.
- Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening or fatal ILD/pneumonitis may occur. Withhold or permanently discontinue EMRELIS based on the severity.
- Ocular Surface Disorders: Monitor patients for signs or symptoms of ocular surface disorders, including vision changes. Withhold or permanently discontinue EMRELIS based on the severity.
- Infusion-Related Reactions (IRR): Monitor patients for IRR. Withhold, reduce the rate of infusion, or permanently discontinue EMRELIS based on the severity. For patients who experience IRR, administer premedications prior to subsequent infusions.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients about the potential risk to a fetus and to use effective contraception.
Adverse Reactions:
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.
Drug Interactions:
Strong CYP3A Inhibitors: concomitant use with EMRELIS may increase the AUC of MMAE. Monitor for increased risk of adverse reactions to EMRELIS.
Use in Specific Populations:
- Severe or Moderate Hepatic Impairment: Avoid use of EMRELIS.
- Lactation: Advise not to breastfeed.
- Infertility: May impair fertility.
Adapted From:
https://www.rxabbvie.com/pdf/emrelis_pi.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
