AbbVie has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for EMRELIS (telisotuzumab vedotin-tllv). This treatment is designed for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) exhibiting high c-Met protein overexpression, who have previously undergone systemic therapy. The FDA's decision was based on the overall response rate and duration of response, with continued approval contingent upon further clinical benefit verification.
Jonathan Goldman, MD, professor of medicine at UCLA, commented on this development: "We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes." He highlighted the critical need addressed by EMRELIS for patients with c-Met overexpressing NSCLC.
Roopal Thakkar, MD from AbbVie emphasized their commitment to developing cancer therapies: "EMRELIS...is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease."
The FDA's approval follows data from the Phase 2 LUMINOSITY study, which indicated a 35% overall response rate among patients treated with EMRELIS. Common side effects included peripheral neuropathy and fatigue. The Roche VENTANA MET (SP44) RxDx Assay has also been approved as a companion diagnostic tool.
Upal Basu Roy from LUNGevity Foundation noted the significance of this targeted therapy: "This approval is a welcomed targeted therapy for those with high c-Met protein overexpressing late-stage, non-small cell lung cancer who have seen very limited treatment innovation in the last decade."
AbbVie is further evaluating EMRELIS in a Phase 3 confirmatory global study named TeliMET NSCLC-01. Information on clinical trials can be found at www.clinicaltrials.gov.
AbbVie offers patient support programs to help manage out-of-pocket costs associated with EMRELIS. More information is available at www.AbbVie.com/PatientAccessSupport.
For more details about AbbVie's work in oncology and other therapeutic areas, visit their website or follow them on social media platforms.