• Daiichi Sankyo’s Enhertu won a positive CHMP opinion for EU approval as monotherapy for adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumors previously treated with no satisfactory options.
• The European Commission will now review the recommendation for a final marketing authorization decision.
• The CHMP opinion was based on Phase 2 data showing objective response rates of 51.4% in DESTINY-PanTumor02, 52.9% in DESTINY-Lung01, 46.9% in DESTINY-CRC02.
• Enhertu is jointly developed and commercialized with AstraZeneca.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Daiichi Sankyo Co. Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 202605220800BIZWIRE_USPR_____20260521_BW833711) on May 22, 2026, and is solely responsible for the information contained therein.