FDA Grants Accelerated Approval to AbbVie's Emrelis for Advanced Lung Cancer Treatment

AbbVie's drug, Emrelis (telisotuzumab vedotin-tllv), has received accelerated approval from the US Food and Drug Administration (FDA) for the treatment of certain lung cancer patients. Specifically, Emrelis is designed for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who exhibit high levels of c-Met protein overexpression and have undergone prior systemic therapy.

In the United States, lung cancer is projected to affect approximately 226,650 individuals this year, with NSCLC comprising around 85% of these cases. Among patients with advanced EGFR wild type, non-squamous NSCLC, about 25% show overexpression of the c-Met protein. This overexpression is associated with a poor prognosis, and nearly half of these patients experience high levels of c-Met protein.

Emrelis is part of an emerging category of drugs known as antibody-drug conjugates (ADCs). These therapies combine the target specificity of antibodies with the powerful cell-killing capabilities of chemotherapy or other anti-cancer agents. Emrelis specifically targets the c-Met protein, offering a pioneering treatment option for patients with limited choices.

Jonathan Goldman, a professor of medicine and director of thoracic oncology clinical trials at UCLA, remarked, "Patients with c-Met overexpressing NSCLC face a dire prognosis and have scant treatment options. Emrelis stands out as a first-in-class ADC that fulfills a significant unmet need for these individuals."

The FDA's approval of Emrelis was largely based on findings from the LUMINOSITY trial, a mid-stage study. The trial demonstrated that Emrelis achieved an overall response rate of 35% with a median response duration of 7.2 months in patients exhibiting high c-Met protein levels. As part of the FDA's accelerated approval process, which aims to hasten the availability of treatments for serious conditions with unmet needs, the ongoing approval of Emrelis for this use may depend on further validation of its clinical benefits through confirmatory trials.

In conjunction with the Emrelis approval, the FDA has also authorized Roche's VENTANA MET (SP44) RxDx Assay. This companion diagnostic test assists in identifying patients with c-Met protein overexpression who might benefit from AbbVie's treatment.

Matt Sause, CEO of Roche Diagnostics, emphasized the importance of understanding molecular drivers in NSCLC patients for optimal treatment selection. He stated, "By pinpointing MET protein expression at the right stage of a patient’s journey, we can offer timely and personalized treatment options. This may enhance patient outcomes and provide hope to those contending with this challenging disease."

In summary, the introduction of Emrelis offers a promising new treatment avenue for NSCLC patients with high c-Met protein expression, addressing a critical gap in current therapeutic options. The associated diagnostic advancements further support tailored treatment strategies, potentially improving prognosis and quality of life for affected individuals.