Astellas' zolbetuximab gains UK approval for gastric cancer

seekingalpha08-14

The UK's Medicines and Healthcare products regulatory agency has approved Astellas Pharma's (OTCPK:ALPMF) Vyloy (zolbetuximab) in combination with chemotherapy to treat gastric or gastro-oesophageal ...

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The approval is for patients who are positive for “Claudin18.2 \" and negative for the “Human epidermal growth factor receptor 2 ” proteins, and is intended for those whose cancer has spread or cannot be removed by surgery.  The MHRA based its decision on two phase 3 trials that showed zolbetuximab led to improved overall survival compared to placebo.  More on Astellas Pharma  Astellas Pharma Inc.  Q1 2024 Earnings Call Transcript Astellas Pharma Inc. 2024 Q1 - Results - Earnings Call Presentation Astellas zolbetuximab resubmission accepted by FDA Astellas Pharma partners with YASKAWA for innovative cell therapy Seeking Alpha’s Quant Rating on Astellas Pharma ADR","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","ALPMF":"Astellas Pharma, Inc."},"translate_title":"安斯泰来的zolbetuximab获得英国批准用于胃癌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ALPMF":1},"content_text":"The UK's Medicines and Healthcare products regulatory agency has approved Astellas Pharma's (OTCPK:ALPMF) Vyloy (zolbetuximab) in combination with chemotherapy to treat gastric or gastro-oesophageal cancer. The approval is for patients who are positive for “Claudin18.2 (CLDN18.2)\" and negative for the “Human epidermal growth factor receptor 2 (HER2)” proteins, and is intended for those whose cancer has spread or cannot be removed by surgery.  The MHRA based its decision on two phase 3 trials that showed zolbetuximab led to improved overall survival compared to placebo.  More on Astellas Pharma  Astellas Pharma Inc. 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