Astellas Pharma has submitted 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) adenocarcinoma patients whose tumours are CLDN18.2-positive.
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: 鈥淕astric 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.
鈥淎stellas鈥� submission of a new drug application to Japan鈥檚 Ministry of Health, Labour and Welfare for zolbetuximab demonstrates critical momentum in addressing the unmet needs of patients with gastric cancer in Japan.鈥�
The submission of the NDA was based on the data obtained from the Phase III SPOTLIGHT and GLOW clinical trials.
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By GlobalDataThe 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.
