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BioNTech and DualityBio Receive FDA Breakthrough Therapy

FDA Grants Breakthrough Therapy Designation to BNT323/DB-1303 in Endometrial Cancer

The FDA has granted breakthrough therapy designation to the HER2-targeted antibody-drug conjugate BNT323/DB-1303 for use as a potential therapeutic option in patients with advanced endometrial cancer who have progressed on or after treatment with immune checkpoint inhibitors.

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