Avenzo Therapeutics Wins Fast Track for Lung Cancer Drug

FDA has granted Avenzo Therapeutics a fast track designation for AVZO-1418, the company’s investigational EGFR/HER3 bispecific antibody-drug conjugate being developed for certain patients with non-small cell lung cancer (NSCLC). The designation covers adults with unresectable, locally advanced or metastatic NSCLC harboring common EGFR-activating mutations — exon 19 deletions or exon 21 L858R — whose cancers have progressed after treatment with an EGFR tyrosine kinase inhibitor, according to the company. These patients frequently develop resistance to first-line targeted therapies and have limited options after tyrosine kinase inhibitor treatment failure.

AVZO-1418, also known as DB-1418, is in a Phase 1-2 first-in-human, open-label study evaluating its safety, tolerability and preliminary antitumor activity both as a monotherapy and in combination regimens across advanced solid tumors.