Emrelis FDA Approval History
Last updated by Judith Stewart, BPharm on May 15, 2025.
FDA Approved: Yes (First approved May 14, 2025)
Brand name: Emrelis
Generic name: telisotuzumab vedotin-tllv
Dosage form: Lyophilized Powder for Injection
Previous Name: Teliso-V
Company: AbbVie Inc.
Treatment for: Non Small Cell Lung Cancer
Emrelis (telisotuzumab vedotin) is a first-in-class, c-Met protein directed antibody-drug conjugate for the treatment of non-squamous non-small cell lung cancer with high c-Met protein overexpression.
- 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, 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). - The c-Met protein is a receptor tyrosine kinase that can be overexpressed in many solid tumors, including NSCLC. Emrelis is an 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.
- The FDA accelerated approval of Emrelis was supported by data from the Phase 2 LUMINOSITY study (NCT03539536). Findings showed that 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).
- Emrelis is administered by intravenous infusion every two weeks until disease progression or unacceptable toxicity.
- Warnings and precautions associated with Emrelis include peripheral neuropathy, interstitial lung disease (ILD)/pneumonitis, ocular surface disorders, infusion-related reactions (IRR), and embryo-fetal toxicity.
- Common adverse reactions (≥20%) include peripheral neuropathy, fatigue, decreased appetite and peripheral edema.
Common Grade 3 or 4 laboratory abnormalities (≥2%) include decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium. - 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.
Development timeline for Emrelis
Further information
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