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U S FDA ACKNOWLEDGES ASTELLAS RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND SETS NEW ACTION DATE

/PRNewswire/ Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA).

United statesUnited kingdomMoitreyee chatterjee kishoreNaoki okamuraRare diseases information centerTranslational sciencesAmerican cancer societyJapan ministry of healthNational institutes of health centerPrnewswire astellas pharma incNational cancer instituteAmerican society of clinical oncologyEnd results programDrug administrationOncology developmentAstellas pharma inc

FDA Accepts BLA Resubmission for Zolbetuximab in CLDN18 2+ Advanced Gastric/GEJ Adenocarcinoma

FDA Accepts BLA Resubmission for Zolbetuximab in CLDN18 2+ Advanced Gastric/GEJ Adenocarcinoma
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United statesMoitreyee chatterjee kishoreAstellas pharmaOncology development at astellasPrescription drug user fee actImmuno oncology development

Japan clears first CLDN18 2 drug, Astellas Vyloy

Astellas is first drugmaker to get approval for a CLDN18.2-targeted therapy as Vyloy (zolbetuximab) is cleared in Japan for gastric cancer.

South koreaGanymed pharmaMerck kgaa hengruiMoitreyee chatterjee kishoreMinistry of healthLeap therapeuticsLegend biotecGastric cancerTargeted oncologyRegulatory approval

Japan s MHLW Approves Zolbetuximab in CLDN18 2-Positive Gastric Cancer

The Japanese Ministry of Health, Labour and Welfare has approved zolbetuximab for CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer.

Kohei shitaraMoitreyee chatterjee kishoreJapan ministry of healthAstellas pharma incDepartment of gastrointestinal oncologyNational cancer center hospitalOncology development at astellasGastrointestinal oncologyNational cancer center hospital eastRoche diagnosticsRxdx assayImmuno oncology development

Manufacturing Issues Block Astellas From a First-in-Class Cancer Drug Approval

Astellas Pharma’s zolbetuximab was on track to become the first gastric cancer drug that targets claudin 18.1, a protein found on cancerous stomach cells. Others with clinical-stage programs addressing this this target include AstraZeneca and Bristol Myers Squibb.

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