AbbVie's Emrelis approved by US FDA for non-small cell lung cancer

(Alliance News) - AbbVie on Wednesday said the US Food & Drug Administration has approved Emrelis for adults with previously treated advanced non-small cell lung cancer with high c-Met protein overexpression.

High c-Met protein overexpression is defined as equal to or more than 50% of tumour cells with strong staining as determined by an FDA-approved test.

The North Chicago, Illinois-based pharmaceuticals firm said 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 confirmatory trials, the firm added.

AbbVie explained the FDA accelerated approval is supported by data from the Phase 2 Luminosity study.

Findings from the study showed patients with high c-Met protein overexpression who received Emrelis demonstrated a 35% ORR and DOR with a median of 7.2 months.

In December 2021, the FDA granted Emrelis Breakthrough Therapy Designation based on Phase 2 Luminosity study data.

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.

Shares in AbbVie were down 4.9% at USD178.86 each in New York on Wednesday.

By Jeremy Cutler, Alliance News reporter

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