Avenzo Therapeutics granted Fast Track Designation for AVZO-1418, a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, for the treatment of patients with EGFR-mutated TKI-pretreated NSCLC

CAR-T Digest - August 2020

Weekly Digest - November 2025

10 November 2025: Avenzo Therapeutics granted Fast Track Designation for AVZO-1418, a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, for the treatment of patients with EGFR-mutated TKI-pretreated NSCLC

Avenzo Therapeutics announced that the FDA has granted Fast Track designation to AVZO-1418, its next-generation EGFR/HER3 bispecific ADC aimed at improving outcomes in hard-to-treat lung cancer
This designation specifically supports patients with unresectable or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations who have already progressed after EGFR TKI therapy
The recognition signals the FDA’s belief in the therapy’s potential, aligning with Avenzo’s confidence in AVZO-1418 as a promising option for TKI-pretreated, EGFR-mutated NSCLC
With Fast Track status in place, Avenzo expects a more efficient development path as it continues to advance AVZO-1418 through its ongoing Phase 1 program
The drug is currently being evaluated in a Phase 1/2 first-in-human trial assessing its safety, tolerability, and early clinical activity both as a monotherapy and in combination treatments for advanced solid tumors