Astellas Pharma Inc Announcement
Tokyo, Oct. 18, 2024, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, Astellas) announced that the United States FDA has approved VYLOY (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.
VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S.
Astellas Pharma Inc. (ALPMY) – A pharmaceutical company conducting business in more than 70 countries around the world. Astellas is promoting the Focus Area Approach designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, the firm is looking beyond the foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients.
In the SPOTLIGHT and GLOW Clinical trials, around 38% of patients screened had positive CLDN18.2 tumors. The CLDN18.2 positivity is defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, as determined by the VENTANA® CLDN18 (43-14A) RxDx Assay from Roche.
Astellas collaborated with Roche on a newly approved immunohistochemistry (IHC) companion diagnostic (CDx) test to identify patients eligible for VYLOY.
From Astellas Pharma and Other Experts
Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas said, “The approval of VYLOY as the first and only targeted therapy for CLDN18.2-positive patients in the U.S. further delivers on our relentless pursuit of scientific progress for devastating diseases like gastric and GEJ cancers, which are often only discovered at the advanced stage. This achievement is a result of years of dedicated research and development focused on targeting a novel biomarker, and we are grateful to the patients, investigators, and Astellas team members who have made this important advancement for patients a reality.”
Samuel J. Klempner, M.D., Associate Professor, Harvard Medical School, Medical Oncologist at Massachusetts General Hospital, Boston said, “While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in the last several years, there is still a tremendous unmet need among our patients. The approval of VYLOY, based on the pivotal Phase 3 SPOTLIGHT and GLOW trials, brings forward a novel biomarker and new therapy for patients whose tumors are CLDN18.2 positive, and for those on the frontlines of treatment decision-making.”
The Basis of the Approval
The approval is based on results from Phase 3 SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated VYLOY plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6. The GLOW study evaluated VYLOY plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.
Both trials met their primary endpoint, progression-free survival (PFS), as well as a key secondary endpoint, overall survival (OS), in patients treated with VYLOY plus chemotherapy compared to placebo plus chemotherapy.
Across the SPOTLIGHT and GLOW trials, the most common all-grade treatment-emergent adverse events (TEAEs) reported in the VYLOY treatment arms were nausea, vomiting, and decreased appetite. An FDA-approved test is used to identify patients who may be eligible for VYLOY.
The VENTANA CLDN18 (43-14A) RxDx Assay from Roche is an FDA-approved IHC test used to help determine CLDN18.2 status. Testing is available in the U.S. at multiple reference laboratories nationwide and is expected to expand to additional laboratories over time.
To see where testing for CLDN18.2 status is available, visit VYLOYhcp.com.*
Following today’s FDA decision, VYLOY is now approved in five markets worldwide — Japan, the United Kingdom, the European Union, South Korea, and the U.S. Japan’s Ministry of Health, Labor and Welfare approved VYLOY for use on March 26, 2024, representing the first global approval of this treatment.
In August, VYLOY was approved by the UK Medicines and Healthcare Products Regulatory Agency.
In September, the European Commission granted marketing authorization to VYLOY in the European Union, and the Ministry of Food and Drug Safety approved the therapy in South Korea.
Astellas submitted other applications for VYLOY to regulatory agencies around the world. Astellas has already reflected the impact of this approval in its financial forecast for the current fiscal year ending March 31, 2025.
About VYLOY™ (zolbetuximab-clzb)
VYLOY™ (zolbetuximab-clzb) is a claudin 18.2-directed cytolytic antibody approved by the U.S. Food and Drug Administration (FDA) 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. As a first-in-class monoclonal antibody (mAb), VYLOY targets and binds to CLDN18.2, a transmembrane protein. VYLOY depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Important to read the Safety Information, Warnings and Precautions, Adverse Effects and More.
Prohost Observations
This is exciting news about VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, getting approval for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive as determined by an FDA-approved test.
Click here to read more about Astellas Pharma.
News & Comments
October 21, 2024
The United States FDA Approved Astellas’ product VYLOY in Combination with Fluoropyrimidine and Platinum-Containing Chemotherapy for the First-Line Treatment of Adults with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Astellas Pharma Inc Announcement
Tokyo, Oct. 18, 2024, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, Astellas) announced that the United States FDA has approved VYLOY (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.
VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S.
Astellas Pharma Inc. (ALPMY) – A pharmaceutical company conducting business in more than 70 countries around the world. Astellas is promoting the Focus Area Approach designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, the firm is looking beyond the foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients.
For more information click the following link: https://www.astellas.com/en.
In the SPOTLIGHT and GLOW Clinical trials, around 38% of patients screened had positive CLDN18.2 tumors. The CLDN18.2 positivity is defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, as determined by the VENTANA® CLDN18 (43-14A) RxDx Assay from Roche.
Astellas collaborated with Roche on a newly approved immunohistochemistry (IHC) companion diagnostic (CDx) test to identify patients eligible for VYLOY.
From Astellas Pharma and Other Experts
Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas said, “The approval of VYLOY as the first and only targeted therapy for CLDN18.2-positive patients in the U.S. further delivers on our relentless pursuit of scientific progress for devastating diseases like gastric and GEJ cancers, which are often only discovered at the advanced stage. This achievement is a result of years of dedicated research and development focused on targeting a novel biomarker, and we are grateful to the patients, investigators, and Astellas team members who have made this important advancement for patients a reality.”
Samuel J. Klempner, M.D., Associate Professor, Harvard Medical School, Medical Oncologist at Massachusetts General Hospital, Boston said, “While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in the last several years, there is still a tremendous unmet need among our patients. The approval of VYLOY, based on the pivotal Phase 3 SPOTLIGHT and GLOW trials, brings forward a novel biomarker and new therapy for patients whose tumors are CLDN18.2 positive, and for those on the frontlines of treatment decision-making.”
The Basis of the Approval
The approval is based on results from Phase 3 SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated VYLOY plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6. The GLOW study evaluated VYLOY plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.
Both trials met their primary endpoint, progression-free survival (PFS), as well as a key secondary endpoint, overall survival (OS), in patients treated with VYLOY plus chemotherapy compared to placebo plus chemotherapy.
Across the SPOTLIGHT and GLOW trials, the most common all-grade treatment-emergent adverse events (TEAEs) reported in the VYLOY treatment arms were nausea, vomiting, and decreased appetite. An FDA-approved test is used to identify patients who may be eligible for VYLOY.
The VENTANA CLDN18 (43-14A) RxDx Assay from Roche is an FDA-approved IHC test used to help determine CLDN18.2 status. Testing is available in the U.S. at multiple reference laboratories nationwide and is expected to expand to additional laboratories over time.
To see where testing for CLDN18.2 status is available, visit VYLOYhcp.com.*
Following today’s FDA decision, VYLOY is now approved in five markets worldwide — Japan, the United Kingdom, the European Union, South Korea, and the U.S. Japan’s Ministry of Health, Labor and Welfare approved VYLOY for use on March 26, 2024, representing the first global approval of this treatment.
In August, VYLOY was approved by the UK Medicines and Healthcare Products Regulatory Agency.
In September, the European Commission granted marketing authorization to VYLOY in the European Union, and the Ministry of Food and Drug Safety approved the therapy in South Korea.
Astellas submitted other applications for VYLOY to regulatory agencies around the world. Astellas has already reflected the impact of this approval in its financial forecast for the current fiscal year ending March 31, 2025.
About VYLOY™ (zolbetuximab-clzb)
VYLOY™ (zolbetuximab-clzb) is a claudin 18.2-directed cytolytic antibody approved by the U.S. Food and Drug Administration (FDA) 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. As a first-in-class monoclonal antibody (mAb), VYLOY targets and binds to CLDN18.2, a transmembrane protein. VYLOY depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Important to read the Safety Information, Warnings and Precautions, Adverse Effects and More.
Prohost Observations
This is exciting news about VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, getting approval for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive as determined by an FDA-approved test.
Click here to read more about Astellas Pharma.
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