AbbVie announces Emrelis granted accelerated approval by FDA

AbbVie (ABBV) announced that Emrelis has been granted accelerated approval by the U.S. Food and Drug Administration for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression who have received a prior systemic therapy. “This indication is approved based on overall response rate and duration of response. 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 and the first and only treatment approved for this patient population. ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent ‘payload’ directly to the biomarker-expressing cell,” the company stated.