NORTH CHICAGO, Ill., May 14, 2025 — AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to EMRELIS™ (telisotuzumab vedotin-tllv) 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 via an FDA-approved IHC test), who have previously received systemic therapy.

This approval is based on overall response rate (ORR) and duration of response (DOR) data from the Phase 2 LUMINOSITY study (NCT03539536). In patients with high c-Met overexpression (n=84), EMRELIS achieved a 35% ORR (95% CI: 24–46) and a median DOR of 7.2 months (95% CI: 4.2–12). Continued approval may be contingent on confirmatory results from the ongoing Phase 3 TeliMET NSCLC-01 trial.

EMRELIS is the first and only approved therapy for this patient population, addressing a significant unmet need in a subgroup of NSCLC patients with poor prognosis and limited treatment options. As an antibody-drug conjugate (ADC), EMRELIS specifically targets c-Met overexpressing tumor cells and delivers a cytotoxic payload.

Clinical Background

  • NSCLC accounts for ~85% of lung cancer cases globally.
  • High c-Met overexpression occurs in ~25% of advanced EGFR wild-type, non-squamous NSCLC, and is associated with poor outcomes.
  • The FDA also approved the VENTANA® MET (SP44) RxDx Assay by Roche as a companion diagnostic for identifying eligible patients.

Safety Profile

The most common adverse reactions (≥20%) include:

  • Peripheral neuropathy
  • Fatigue
  • Decreased appetite
  • Peripheral edema

Common Grade 3/4 laboratory abnormalities (≥2%) include:

  • Decreased lymphocytes
  • Elevated glucose, ALT, and GGT
  • Electrolyte imbalances (phosphorus, sodium, calcium)
  • Anemia

Patient Access

AbbVie is offering financial assistance and patient support programs, including myAbbVie Assist, to help eligible patients access EMRELIS.

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Expert Commentary

“People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options,” said Dr. Jonathan Goldman, Director of Thoracic Oncology Clinical Trials at UCLA. “EMRELIS represents a first-in-class ADC that addresses a critical unmet need.”

About EMRELIS

EMRELIS is a c-Met-directed antibody-drug conjugate composed of a monoclonal antibody, cleavable linker, and monomethyl auristatin E (MMAE) payload. It is administered via IV infusion every two weeks.

For More Information:

Media Contact:
Stephanie Tennessen – (224) 214-8638 – stephanie.tennessen@abbvie.com

Investor Contact:
Liz Shea – (847) 935-2211 – liz.shea@abbvie.com

Source: AbbVie