FDA Granted Fast Track Designation for AVZO-1418 for the Treatment of Patients with EGFR-Mutated TKI-Pretreated NSCLC

“We are excited to receive this Fast Track designation from the FDA, underscoring the promise of AVZO-1418, especially for patients with EGFR-Mutated TKI-Pretreated NSCLC,” said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. “This designation has the potential to help expedite the development of AVZO-1418, which we continue to rapidly advance in Phase 1.”

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