Astellas Wins Approval For Vyloy, Making Claudin 18.2 Testing Critical

An exec said the company is confident it can ensure testing for the biomarker becomes routine for the drug, which is the first FDA-approved medicine to target CLDN18.2.

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Astellas is confident that it can ensure widespread testing for Claudin18.2 (CLDN18.2) among patients with gastric and gastroesophageal junction (G/GEJ) cancer as the first company to win approval for a drug targeting that biomarker, Vyloy (zolbetuximab-clzb).

The US Food and Drug Administration approved Vyloy on 18 October in combination with fluoropyrimidine- and platinum-containing chemotherapy for adults...

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