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The U.S. Food and Drug Administration (FDA) granted accelerated approval to AbbVie Inc.’s (NYSE:ABBV) Emrelis (telisotuzumab vedotin-tllv) for 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), the company said in a statement on Wednesday.
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Emrelis is a c-Met-directed antibody-drug conjugate (ADC) 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.
Data from the Phase 2 LUMINOSITY study, designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations, support the FDA’s accelerated approval.
Findings from the study showed patients with high c-Met protein overexpression (n=84) who received Emrelis demonstrated a 35% Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months.
In December 2021, the FDA granted EMRELIS Breakthrough Therapy Designation (BTD) based on Phase 2 LUMINOSITY study data.
Emrelis is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01.
Enrollment in the study is underway and continues across global clinical trial sites.
The FDA has also approved Roche Holdings AG’s (OTC:RHHBY) VENTANA MET (SP44) RxDx Assay, the only IHC companion diagnostic identifying patients eligible for Emrelis treatment.
On Wednesday, AbbVie and ADARx Pharmaceuticals announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology, and oncology.
siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates gene expression. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins.