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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).

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

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.

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.

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.