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

www.onclive.com/view/fda-gra...
FDA Grants Fast Track Designation to AVZO-1418/DB-1418 for EGFR+, TKI-Pretreated NSCLC | OncLive
AVZO-1418/DB-1418 has received fast track designation from the FDA for patients with advanced, EGFR-mutant NSCLC following prior therapy with an EGFR TKI.
www.onclive.com
November 12, 2025 at 5:03 PM
LucidQuest YouTube > Trending in Oncology: Keytruda SC EU, Libtayo Adjuvant, HYRNUO and more: Oncology Update spotlights major moves: the European Commission approved KEYTRUDA SC across all adult indications with 1–2 minute administration, and Libtayo… Subscribe for more! #LucidQuest #PharmaCI
Trending in Oncology: Keytruda SC EU, Libtayo Adjuvant, HYRNUO and more
Oncology Update spotlights major moves: the European Commission approved KEYTRUDA SC across all adult indications with 1–2 minute administration, and Libtayo gained adjuvant approval in high-risk CSCC after C-POST showed a 68 percent reduction in recurrence or death, HR 0.32. Avenzo’s AVZO-1418 received FDA Fast Track for EGFR-mutated NSCLC post-TKI, while Bayer’s HYRNUO won US accelerated approval in HER2-mutated non-squamous NSCLC. Plus, Celcuity filed a gedatolisib RTOR NDA, BetaGlue’s YntraDose CTA cleared, ITM’s 177Lu-edotreotide NDA was accepted, and FDA aligned Alpha1H’s pivotal design for NMIBC.
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November 24, 2025 at 12:24 PM