ASCO: As FDA’s Zolbetuximab Decision Looms, Astellas Looks To Meet Testing Challenge

 
• By Alaric DeArment
  
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Scrip sat down with Astellas chief medical officer Tadaaki Taniguchi to talk about the drug maker’s plans for taking its Claudin18.2-targeting drug to the US market.

Astellas stand at ASCO 2024
• Source: Scrip

With the US Food and Drug Administration having accepted Astellas Pharma, Inc.’s refiling of zolbetuximab, its Claudin18.2-targeting drug for gastric and gastroesphageal junction (G/GEJ) cancer, the company is now working to address the challenge of finding patients who express the target, given that testing for it is currently limited to large academic cancer centers.

The drug maker announced the FDA’s acceptance of its resubmitted biologics license application on 30 May, which the agency assigned...

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