Drugs / zolbetuximab
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed gastroesophageal adenocarcinoma 6 milestones | |||||
| Filed | US (FDA) | — | gastroesophageal adenocarcinoma | 2024-05-09 | “The zolbetuximab BLA was resubmitted on May 9, 2024” astellas.com ↗ |
| Rejected (CRL) | US (FDA) | — | gastroesophageal adenocarcinoma | 2024-01-04 | “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” astellas.com ↗ |
| Filed | China (NMPA) | — | gastroesophageal adenocarcinoma | 2023-07-31 | “the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for zolbetuximab” astellas.com ↗ |
| Filed | EU (EMA) | — | gastroesophageal adenocarcinoma | 2023-07-13 | “today announced the European Medicines Agency (EMA) has accepted for regulatory review the company’s marketing authorization application (MAA) for zolbetuximab” astellas.com ↗ |
| Filed | US (FDA) | — | gastroesophageal adenocarcinoma | 2023-07-06 | “today 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” astellas.com ↗ |
| Filed | Japan (PMDA) | — | gastroesophageal adenocarcinoma | 2023-06-09 | “today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab” astellas.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Vyloy | — | 2024-09-19 | europa.eu ↗ |
Trials 20
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2025-10-13 | Astellas Pharma Inc | Results Astellas Confirms Phase 2 GLEAM Trial Did Not Meet Primary Endpoint of Overall Survival in Patients with Metastatic Pancreatic Cancer astellas.com ↗ |
| 2025-01-06 | Astellas Pharma Inc | Regulatory China’s National Medical Products Administration (NMPA) Approves VYLOY TM (zolbetuximab) for First-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma astellas.com ↗
Zolbetuximab is the first NMPA-approved monoclonal antibody to target gastric tumor cells that express the biomarker CLDN18.2, offering a highly targeted approach to cancer treatment. |
| 2024-10-21 | Astellas Pharma Inc | Regulatory Astellas’ VYLOY TM (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY TM (zolbetuximab-clzb) in combination 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 claudin (CLDN) 18.2 positive as determined by an FDA-approved test. |
| 2024-09-24 | Astellas Pharma Inc | Regulatory Astellas Receives Approval from the European Commission for VYLOY TM (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer astellas.com ↗
today announced that the European Commission (EC) has approved VYLOY TM (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy |
| 2024-07-26 | Astellas Pharma Inc | Regulatory Astellas Receives Positive CHMP Opinion for Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of zolbetuximab in the European Union. |
| 2024-05-30 | Astellas Pharma Inc | Regulatory U.S. FDA ACKNOWLEDGES ASTELLAS’ RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND SETS NEW ACTION DATE astellas.com ↗
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a new target action date of November 9, 2024. |
| 2024-03-26 | Astellas Pharma Inc | Regulatory Astellas’ VYLOY TM (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer astellas.com ↗
VYLOY is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world. |
| 2024-01-08 | Astellas Pharma Inc | Regulatory Astellas Provides Update on Zolbetuximab Biologics License Application in U.S. astellas.com ↗
The FDA stated that the agency cannot 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. |
| 2023-07-31 | Astellas Pharma Inc | Regulatory China’s National Medical Products Administration Accepts Astellas’ Biologics License Application for Zolbetuximab astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the 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. |
| 2023-07-13 | Astellas Pharma Inc | Regulatory European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Zolbetuximab astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the European Medicines Agency (EMA) has accepted for regulatory review the company’s marketing authorization application (MAA) 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. |
| 2023-07-06 | Astellas Pharma Inc | Regulatory Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application astellas.com ↗
The FDA’s acceptance of the Biologics License Application filing and Priority Review designation for zolbetuximab confirms the urgent therapeutic need and brings us one step closer to delivering on this commitment to patients, families and caregivers. |
| 2023-06-09 | Astellas Pharma Inc | Regulatory Astellas Submits New Drug Application for Zolbetuximab in Japan astellas.com ↗
Astellas’ submission of a New Drug Application to Japan’s Ministry of Health, Labour and Welfare for zolbetuximab demonstrates critical momentum in addressing the unmet needs of patients with gastric cancer in Japan. |
| 2023-04-14 | Astellas Pharma Inc | Results Results from Astellas’ Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet astellas.com ↗ |
| 2023-03-22 | Astellas Pharma Inc | Results Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series astellas.com ↗
In the study, investigational treatment zolbetuximab plus CAPOX demonstrated a statistically significant improvement in progression-free survival (PFS) compared to placebo plus CAPOX. |
| 2023-01-19 | Astellas Pharma Inc | Results Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium astellas.com ↗
In the study, investigational treatment zolbetuximab plus mFOLFOX6 demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to placebo plus mFOLFOX6. |
| 2022-12-16 | Astellas Pharma Inc | Results 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 astellas.com ↗
The GLOW study met its primary endpoint showing statistical significance in progression-free survival (PFS) for patients treated with zolbetuximab plus CAPOX compared to placebo plus CAPOX. |
| 2022-11-17 | Astellas Pharma Inc | Results 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 astellas.com ↗
The study met its primary endpoint showing statistical significance in progression-free survival (PFS) for patients treated with zolbetuximab plus mFOLFOX6 compared to placebo plus mFOLFOX6. |
All press releases naming this drug 18 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zolbetuximab | “the first-in-class monoclonal antibody, zolbetuximab (formerly known as IMAB362), binds to CLDN18.2 and can induce immune-mediated lysis of CLDN18.2-positive cells.” PMID 31240302 ↗ Sep 201920“PURPOSE: Zolbetuximab (IMAB362) is engineered to induce antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity.” PMID 36607429 ↗ Jan 2023 “Biomarker selected patients will receive trastuzumab, zolbetuximab or any other targeted agent according to standard of care.” NCT07000253 ↗ |
| Known as | Claudiximab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00909025 ↗ |
| Known as | IMAB362 | “A Global, Multicenter, Open-label, Early Access Program for Zolbetuximab (IMAB362) Plus mFOLFOX6 or CAPOX in Patients With Claudin18.2-Positive, HER2-Negative, Locally Advanced...” NCT06048081 ↗2“the first-in-class monoclonal antibody, zolbetuximab (formerly known as IMAB362), binds to CLDN18.2 and can induce immune-mediated lysis of CLDN18.2-positive cells.” PMID 31240302 ↗ Sep 2019 “PURPOSE: Zolbetuximab (IMAB362) is engineered to induce antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity.” PMID 36607429 ↗ Jan 2023 |
| Known as | Vyloy | “Zolbetuximab (Vyloy) is a cancer medicine that is used to treat adults with gastric or gastro-esophageal junction adenocarcinoma” NCT06962137 ↗ |
| Known as | Zolbetuximab-clzb | ChEMBL registry synonym — accepted as the source's own label CHEMBL2109427 ↗ |
| Action | Deplete | “can induce immune-mediated lysis of CLDN18.2-positive cells” PMID 31240302 ↗ Sep 2019 |
| Modality | Monoclonal antibody | “first-in-class monoclonal antibody” PMID 31240302 ↗ Sep 2019 |
| Route | Intravenous | “received zolbetuximab intravenously” PMID 31240302 ↗ Sep 2019 |
| Target | CLDN18 | “binds to CLDN18.2” PMID 31240302 ↗ Sep 2019 |