AstraZeneca and Daiichi Sankyo have announced another FDA nod for Enhertu (trastuzumab deruxtecan) for the treatment of unresectable or metastatic HER2-positive solid tumors in adult patients who have exhausted other treatment options.
This marks the fifth approved indication for Enhertu, following its demonstrated efficacy in a series of phase 2 trials across various tumor types. The FDA's accelerated approval for the indication was based on the significant response rates observed in these studies, making Enhertu the first tumor-agnostic HER2-directed therapy.
The approval is grounded in outcomes from three phase 2 trials, which collectively showed a clinically meaningful response in patients with HER2-expressing metastatic cancers. According to AstraZeneca, Enhertu's safety and efficacy were thoroughly assessed in over 300 patients across multiple trials, which confirmed its safety profile and benefits.
Back in 2019, AstraZeneca inked a deal worth $6.9 billion with Daiichi Sankyo to jointly commercialize Enhertu, which at the time was in development for the treatment of multiple HER2-expressing cancers. The drug — now a blockbuster with worldwide sales of $2.5 billion last year — was first approved in late 2019 for HER2-positive metastatic breast cancer and now holds additional approvals for HER2-low breast cancer, HER2-mutant non-small cell lung cancer, and HER2-positive esophagus cancer.
The drug's review process benefited from the FDA’s real-time oncology review program, priority review, and Breakthrough Therapy designation.
