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EGF816 + gefitinib is an investigational combination therapy of two EGFR tyrosine kinase inhibitors (TKIs) being studied in patients with advanced EGFR mutation-positive non-small cell lung cancer (NSCLC). EGF816 (also known as nazartinib) is a third-generation, irreversible EGFR TKI that selectively inhibits both common activating mutations of EGFR and the resistance-conferring T790M mutation. Gefitinib is a first-generation EGFR TKI approved for use in EGFR mutation-positive NSCLC and acts as a reversible inhibitor. The combination is being studied to determine if dual inhibition of EGFR, potentially with different mutation or resistance profiles, can improve outcomes or overcome resistance mechanisms compared to monotherapy. EGF816 has not been approved for any indication; gefitinib is approved for EGFR-mutant NSCLC[1][2].
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