FDA Grants Fast Track Designation to AVZO-1418/DB-1418 for EGFR+, TKI-Pretreated NSCLC

The FDA has granted fast track designation to the EGFR/HER3 bispecific antibody-drug conjugate (ADC) AVZO-1418/DB-1418 for the treatment of patients with unresectable, locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring an EGFR exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after therapy with an EGFR TKI.¹

In January 2025, Avenzo Therapeutics announced that it had entered into an exclusive license agreement with Duality Bio, in which Avenzo will develop, manufacture, and commercialize AVZO-1418/DB-1418 globally, barring China.²

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