Zolbetuximab FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 9, 2024.

FDA Approved: No
Generic name: zolbetuximab
Company: Astellas Pharma US, Inc.
Treatment for: Gastric Cancer

Zolbetuximab is an investigational, first-in-class chimeric IgG1 monoclonal antibody targeting Claudin 18.2 (CLDN18.2) in development for the treatment of patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Gastric cancer is a cancer of the stomach, and gastroesophageal junction (GEJ) adenocarcinoma is a cancer that starts at the area where the esophagus joins the stomach. Claudin 18.2 (CLDN18.2) is a transmembrane protein on the cancer cell surface of gastric epithelial cells.
Zolbetuximab binds to CLDN18.2 induce cancer cell death by activating two distinct immune system pathways - antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Astellas Pharma Inc. has submitted a Biologics License Application (BLA) for zolbetuximab based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.
In July 2023, Astellas announced that the U.S. Food and Drug Administration (FDA) had accepted and granted Priority Review for the BLA for zolbetuximab. On January 8, 2024, the FDA stated that the agency could approve the BLA by the Prescription Drug User Fee Act (PDUFA) action date of January 12, 2024, due to unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab. The FDA did not raise any concerns related to the clinical data, including efficacy or safety, of zolbetuximab, and did not request additional clinical studies.

Development timeline for zolbetuximab

Date	Article
Jan 8, 2024	Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
Jul 6, 2023	Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application
Apr 14, 2023	Results from Astellas' Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet
Mar 21, 2023	Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series
Dec 15, 2022	Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Nov 17, 2022	Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 SPOTLIGHT Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-Negative Locally Advanced or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers

Further information

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