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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 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

Astellas Provides Update on Zolbetuximab Biologics License Application in U S

TOKYO, Jan. 8, 2024 /PRNewswire/ Astellas Pharma Inc. today announced the U.S. Food and Drug Administration issued a complete response letter on January 4, 2024, regarding the Biologics License.

Moitreyee chatterjee kishoreNaoki okamuraOncology developmentAstellas pharma incPrnewswire astellas pharma incDrug administrationBiologics license applicationPrescription drug user fee actSenior vice presidentImmuno oncology developmentPriority reviewZolbetuximab biologics licenseFocus area approach

FDA Issues CRL to Zolbetuximab for Advanced HER2–, CLDN18 2+ Gastric/GEJ Cancer

The FDA has issued a complete response letter regarding the biologics license application seeking the approval of zolbetuximab for the treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin18.2 positive

Astellas pharmaMoitreyee chatterjee kishoreOncology developmentPrescription drug user fee actImmuno oncology developmentBangy jGastric cancerComplete response letterGastroesophageal junction adenocarcinomaLocally advanced unresectable or metastatic her2 negativeClaudin18 2