Astellas Pharma's VYLOY Receives FDA Approval For Treatment Of Advanced Gastric And GEJ Cancer

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) said that the U.S. Food and Drug Administration has approved VYLOY (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.

VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive.

Astellas collaborated with Roche on the newly approved immunohistochemistry (IHC) companion diagnostic (CDx) test to identify patients who may be eligible for VYLOY.

In a separate press release, Roche (RHHBY) said that the VENTANA CLDN18 (43-14A) RxDx Assay is the first U.S. Food and Drug Administration approved immunohistochemistry (IHC) companion diagnostic for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. The patients now may be eligible for treatment with Astellas' targeted therapy VYLOY (zolbetuximab).

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