FDA Grants Accelerated Approval to Emrelis for NSCLC With High C-Met Protein Overexpression

The FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie), a c-Met−directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (≥50% of tumor cells with strong [3+] staining), as determined by an FDA-approved test, who have received a prior systemic therapy.

The agency also approved the VENTANA MET (SP44) RxDx Assay (Roche