LONDON (dpa-AFX) - AstraZeneca PLC (AZN), Monday announced that the company's supplemental Biologics License Application for IMFINZI has been granted Priority Review and Breakthrough Therapy Designation in the U.S. for the treatment of patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers.
The Prescription Drug User Fee Act date is anticipated during the fourth quarter of 2025.
The decision was based on the findings of MATTERHORN Phase III trial, which demonstrated a statistically significant and clinically meaningful event-free survival benefit.
If approved, IMFINZI will be the first and only perioperative immunotherapy-based regimen in this setting.
Meanwhile, regulatory applications for IMFINZI are currently under review in the EU, Japan and several other countries.
In the pre-market hours, AZN is trading at $73.06, up 0.55 percent on the Nasdaq.
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