Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1725 |
| INN | Zolbetuximab |
| Status | Approved |
| Drug code(s) | iMAB362, Claudiximab, GC-182 |
| Brand name | VYLOY |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Claudin-18.2 |
| Indications of clinical studies | Pancreatic cancer, CLDN18.2-positive Gastric Adenocarcinoma; CLDN18.2-positive Adenocarcinoma of Esophagus; CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2009 |
| Start of Phase 2 | September 15, 2010 |
| Start of Phase 3 | January 15, 2018 |
| Date BLA/NDA submitted to FDA | May 09, 2024 |
| Year of first approval (global) | 2024 |
| Date of first US approval | October 18, 2024 |
| INN, US product name | Zolbetuximab, zolbetuximab-clzb |
| US or EU approved indications | First-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test. |
| Company | Astellas |
| Licensee/Partner | None |
| Comments about company or candidate | On October 18, 2024, the Food and Drug Administration approved zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test. Sep 2024: Zolbetuximab approved in the European Union to target claudin 18.2, in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. August 14, 2024: Approved by the Medicines and Healthcare products Regulatory Agency EMA positive opinon announced July 26, 2024. May 30, 2024 I Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company’s resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational claudin (CLDN) 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive. FDA has set a new target action (PDUFA) date of November 9, 2024. March 26, 2024 I Astellas Pharma Inc. announced that on March 26, 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYLOY™ (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. January 8, 2024 I Astellas Pharma Inc. announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024, regarding the Biologics License Application (BLA) for zolbetuximab, an investigational agent for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. EU review started July 13, 2023. July 6, 2023 I Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in the U.S. for these patients. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of January 12, 2024. The FDA reviewed the application under its Real-Time Oncology Review (RTOR) program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. June 9, 2023: Astellas Pharma Inc. announced the submission of a New Drug Application to Japan's Ministry of Health, Labour and Welfare for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. Mar 2023: Two statistically significant Phase 3 trials, GLOW and SPOTLIGHT, to serve as the basis for global regulatory submissions NCT03653507 Phase 3 active not recruting as of last update in Mar 2023; NCT03816163 Phase 2 in pancreatic cancer recruiting as of last update in Jan 2023. May 2021: Reg. filing planned in FY2022 (April 1, 2022 to March 31, 2023; https://sw4503.swcms.net/en/ir-library/ir-meetings/inframe/main/09/teaserItems1/07/linkList/0/link/210526_Astellas_CSP2021_External_EN.pdf Two Phase 3 studies (NCT03653507 and NCT03504397) recruiting as of Jan 2021. NCT03816163 Phase 2 study in pancreatic cancer started recruiting in March 2019. NCT03653507 Phase 3 study started in Sep 2018. Listed as Phase 3 in US, Europe, Japan and Asia for gastric and gastroesophageal junction adenocarcinoma in Astellas pipeline dated July 30, 2019 and Jan 31, 2018; NCT03504397 Phase 3 study as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma started in June 2018. Dec 2016: Astellas acquires Ganymed Pharmaceuticals June 2016: Findings from the European phase II FAST study showed that the novel, first-in-class antibody IMAB362 can significantly extend median survival when added to standard chemotherapy (13.2 vs 8.4 months) for patients with advanced gastric cancer. This therapy targets a protein called claudin-18 splice variant 2 (CLDN18.2), and patients in the study with the highest levels of CLDN18.2 had an even longer median overall survival (16.7 months). Orphan designation EU for gastric and pancreatic cancer, and in US for pancreatic cancer; Ganymed expects to complete patient enrollment in the Phase IIb FAST study of IMAB362 in the second quarter of 2014 |
| Full address of company | 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan Asia Japan https://www.astellas.com/en/contact-us |
Target is a tight junction protein
| Anticipated events | Review in China with decision expected in Q4 2024 |
| Factor(s) contributing to discontinuation | None |