The U.S. Food and Drug Administration has given accelerated approval to AbbVie’s drug EMRELIS for adults with a type of advanced lung cancer called non-squamous non-small cell lung cancer (NSCLC). This approval is for patients whose tumors have high levels of a protein called c-Met and who have already received other treatments. EMRELIS is a targeted therapy that combines an antibody with a cancer-fighting drug to attack cancer cells more precisely. This approval is based on overall response rate (ORR) and duration of response (DOR), with continued approval contingent on confirmatory trial outcomes. The approval follows results from the Phase 2 LUMINOSITY trial, which showed an ORR of 35% and a median DOR of 7.2 months among patients with high c-Met protein expression. EMRELIS is the first approved therapy specifically targeting this population. The most common adverse reactions included fatigue, peripheral neuropathy, and decreased appetite.
Dr. Jonathan Goldman of UCLA stated, “People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and EMRELIS is a first-in-class ADC that can address a critical unmet need for this patient population.” AbbVie’s Chief Scientific Officer, Dr. Roopal Thakkar, added, "EMRELIS, AbbVie's first internally developed solid tumor medicine and our first solid tumor FDA approval in lung cancer, is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease." A Phase 3 confirmatory trial is ongoing, and the FDA has approved the Roche VENTANA MET (SP44) RxDx Assay as the companion diagnostic for EMRELIS.
