British-Swedish pharmaceutical and biotechnology company AstraZeneca plc (LSE:AZN)(STO:AZN) and Daiichi Sankyo, a Japanese pharmaceutical company, announced on Monday that the co-developed Enhertu has gained FDA approval in the US as the initial tumour-agnostic HER2-targeted therapy for previously treated metastatic HER2-positive solid tumours, following positive outcomes in three Phase II trials.

This approval marks Enhertu's fifth indication, specifically for HER2-expressing metastatic cancers. The FDA granted this approval under accelerated approval, relying on objective response rate (ORR) and duration of response (DoR), with continued approval contingent upon further clinical validation.

Enhertu, an engineered HER2-directed antibody drug conjugate (ADC), demonstrated significant efficacy across various tumor types. It achieved a confirmed ORR of 51.4% in solid tumours including biliary tract, bladder, and pancreatic cancers. Safety assessments across trials showed no new concerns.

The NCCN Guidelines now include Enhertu as a treatment option for multiple metastatic tumors. Its approval was expedited through the FDA's Real-Time Oncology Review program, supported by Priority Review and Breakthrough Therapy Designation.

Furthermore, Enhertu's regulatory review is underway in Australia, Brazil, and Singapore through Project Orbis, facilitating simultaneous global submissions and evaluations.