AstraZeneca expands oncology portfolio with Enhertu approval and ZEGFROVY license

AstraZeneca is expanding its oncology portfolio through a major regulatory approval in Europe and a significant licensing agreement for lung cancer treatment.

The European Commission has approved Enhertu (trastuzumab-deruxtecan) in combination with pertuzumab for the first-line treatment of patients with HER2-positive metastatic breast cancer who have not previously received systemic therapy. This approval is supported by data from the DESTINY-Breast09 study.

Additionally, AstraZeneca has finalized a licensing agreement with Dizal Pharmaceutical to acquire exclusive global rights to ZEGFROVY (sunvozertinib). This oral EGFR inhibitor is used to treat non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. While already approved in China, AstraZeneca plans to launch the therapy in the United States in the fourth quarter of 2026. The company has also submitted a supplemental application to the FDA seeking approval for first-line use based on Phase III trial results.