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# AbbVie’s Emrelis Approved for Lung Cancer
- URL: https://www.fdaweb.com/abbvies-emrelis-approved-for-lung-cancer/
- Published: 2025-05-14T12:00:00.000Z
- Updated: 2026-09-14T15:11:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159182

FDA has granted AbbVie accelerated approval for its Emrelis (telisotuzumab vedotin-tllv) for treating adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression.

Approval was based on overall response rate and duration of response data. “Findings from the study showed patients with high c-Met protein overexpression (n=84) who received EMRELIS demonstrated a 35% (95% CI: 24, 46) overall response rate and duration of response with a median of 7.2 months (95% CI: 4.2, 12),” AbbVie says.

The most common adverse reactions (experienced in greater than 20% of patients) were peripheral neuropathy, fatigue, decreased appetite and peripheral edema, it says, adding that the most common Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium.