The U.S. Food and Drug Administration has granted accelerated approval to AbbVie’s Emrelis, a targeted therapy for adults with advanced non-squamous non-small cell lung cancer (NSCLC) who have undergone prior treatment, the company announced Wednesday.
Emrelis is an antibody-drug conjugate designed to deliver cancer-fighting agents directly to tumor cells, limiting damage to healthy tissue.
The drug targets tumors with high levels of the c-Met protein, which contributes to cancer progression and resistance to standard therapies.
Around 25%–37% of patients with this NSCLC subtype overexpress c-Met, according to the National Institutes of Health. NSCLC is the most common form of lung cancer in the U.S., accounting for an estimated 197,000 new cases annually.
The FDA’s decision was based on results from a mid-stage clinical trial involving 84 patients, where Emrelis achieved an overall response rate of 35%. A larger, late-stage trial is ongoing to further evaluate its effectiveness and safety.
Emrelis adds to the expanding list of NSCLC treatment options, which already includes Merck’s immunotherapy Keytruda and AstraZeneca’s targeted therapy Tagrisso.
AbbVie’s approval underscores the growing role of precision medicine in oncology, offering a more tailored approach for patients with limited options.
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