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Astellas Wins Approval For Vyloy, Making Claudin 18.2 Testing Critical

 
• By Alaric DeArment

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.

(Shutterstock)

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 with first-line locally advanced unresectable or metastatic HER2-negative G/GEJ adenocarcinoma...

Key Takeaways
  • The FDA approved Astellas’s Vyloy and a companion diagnostic from Roche for Claudin 18.2-positive gastric/gastroesophageal junction cancer.
  • The drug is the first...

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