BRIEF—Enhertu granted full approval in Japan

Japanese drug developer Daiichi Sankyo has secured full Japanese approval for Enhertu (trastuzumab deruxtecan), a third generation HER2-directed antibody-drug conjugate (ADC).

The product, which is being jointly developed and commercialized with UK pharma major AstraZeneca, has been approved for certain adults with breast cancer, in the second-line setting.

The nod was based on confirmatory results from the Phase III DESTINY-Breast03 study, which showed a 72% reduction in the risk of disease progression or death, compared to Roche’s (ROG: SIX) alternative, Kadcyla (trastuzumab emtansine).

The firm received conditional early approval in Japan in March 2020.

R&D head Wataru Takasaki said his firm was “proud of the quality and speed in which we were able to deliver a confirmatory Phase III trial that demonstrated the superiority of Enhertu” for this patient population.