The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Emrelis (telisotuzumab vedotin), AbbVie’s investigational antibody-drug conjugate (ADC) for the treatment of adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors exhibit high levels of c-Met protein expression.
Emrelis is designed to selectively target the c-Met receptor, a tyrosine kinase that plays a key role in tumor growth, invasion and metastasis. By linking a monoclonal antibody directed against c-Met with a potent cytotoxic agent, the drug enables targeted delivery of chemotherapy directly into cancer cells, sparing most healthy tissues and reducing systemic toxicity.
The approval was primarily supported by results from a Phase 2 clinical trial in which Emrelis achieved a 35% overall response rate (ORR), with some patients experiencing durable tumor shrinkage. This is particularly significant for NSCLC patients who have progressed on or are ineligible for standard therapies, and who have limited treatment options.
Emrelis is intended for use in patients whose tumors demonstrate high c-Met expression as determined by an FDA-approved companion diagnostic test. The drug represents a significant step forward in personalized medicine for lung cancer, especially in targeting molecular subtypes that are historically difficult to treat.
AbbVie is continuing to evaluate Emrelis in confirmatory studies to verify its clinical benefit and meet post-marketing requirements under the FDA’s accelerated approval pathway. This approval highlights the growing role of antibody-drug conjugates in the evolving landscape of precision oncology.
Disclaimer: This news article is intended for informational purposes only and does not constitute medical advice. The safety and efficacy of Emrelis continue to be evaluated in ongoing clinical trials. Patients should consult their healthcare providers to determine the most appropriate treatment based on their individual medical condition.
