AbbVie Advances Solid Tumor Program with FDA Approval of Emrelis for Lung Cancer

AbbVie's Emrelis (telisotuzumab vedotin-tllv), a c-Met-directed antibody-drug conjugate (ADC), has received accelerated approval from the FDA for treating adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received prior systemic therapy345.

High c-Met protein overexpression is defined as at least 50% of tumor cells displaying strong (3+) staining as determined by an FDA-approved test3.

This approval is based on results from the Phase II LUMINOSITY trial, in which Emrelis showed a 35% overall response rate (ORR) in patients with high c-Met expression and a median response duration of 7.2 months4.

Continued approval may depend on the results of ongoing confirmatory trials, including the Phase III TeliMET NSCLC-01 study34.

Emrelis is the first and only approved treatment specifically for this NSCLC patient population, highlighting AbbVie’s growing commitment to the solid tumor oncology market35.

This marks AbbVie’s first FDA-approved, internally developed solid tumor drug for lung cancer, expanding its oncology portfolio and solidifying its presence in the solid tumor space15.

Sources:

1. https://medcitynews.com/2025/05/abbvie-lung-cancer-fda-antibody-drug-conjugate-solid-tumor-adc-nsclc-abbv/

3. https://www.thepharmaletter.com/fda-approves-abbvies-emrelis

4. https://www.biospace.com/fda/abbvies-adc-nabs-accelerated-approval-for-lung-cancer

5. https://www.fiercepharma.com/pharma/abbvie-advances-solid-tumor-agenda-fda-nod-lung-cancer-adc-emrelis