FDA Approves AbbVie’s Emrelis

Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the US Food and Drug Administration (FDA), said the drug’s developer, AbbVie (NYSE: ABBV).

Emrelis is now authorized 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 (OE) who have received a prior systemic therapy. High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test.

This indication is approved 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). Emrelis is a c-Met-directed antibody-drug conjugate (ADC) and the first and only treatment approved for this patient population, AbbVie noted.