Astellas Pharma files NDA for zolbetuximab to Japan’s MHLW
12 Jun 2023
Clinical ResultNDAPhase 3
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Source: Pharmaceutical Technology
Astellas Pharma’s zolbetuximab will be used to treat advanced gastric and gastroesophageal cancer. Credit: David A Litman via Shutterstock.com.
Astellas Pharma has submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab as a treatment option for advanced gastric and gastroesophageal cancer.
Zolbetuximab is an investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody that is a first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinomaHER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma patients whose tumours are CLDN18.2-positive.
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The drug will become the first CLDN18.2-targeted therapy available in Japan.
Astellas Pharma executive director and immuno-oncology development interim head Pranob Bhattacharya stated: “Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer.
“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.”
The submission of the NDA was based on the data obtained from the Phase III SPOTLIGHT and GLOW clinical trials.
The SPOTLIGHT trial assessed zolbetuximab in combination with modified FOLFOX6 (mFOLFOX6) against placebo and mFOLFOX6.
mFOLFOX6 includes a combination of leucovorin, oxaliplati and fluorouracil.
The GLOW study assessed zolbetuximab along with CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) against placebo and CAPOX.
CAPOX is a chemotherapy combination that includes the drugs oxaliplatin and capecitabine.
38% of the screened patients in both trials had CLDN18.2-positive tumours.
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