Form 6-K Filing Summary

This report details AstraZeneca PLC's announcement regarding Enhertu's recommendation for approval in the EU by the Committee for Medicinal Products for Human Use (CHMP). The recommendation is for Enhertu as a monotherapy to treat adult patients with previously treated, unresectable or metastatic HER2-positive solid tumors who have no satisfactory treatment options. This positive opinion is based on Phase II trial data (DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02) showing clinically meaningful responses across a variety of tumors. If approved, Enhertu would be the first HER2-directed antibody drug conjugate to receive a tumor-agnostic indication in the EU. The filing also provides extensive background on Enhertu, its development, clinical trials, and AstraZeneca's broader oncology and breast cancer strategies, including collaborations and other approved indications worldwide.