Two new 'Breakthrough' designations for Enhertu in USA

31 August 2023

Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy designations (BTDs) in the USA.

The first is for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, while the second is for the treatment of patients with HER2 positive (IHC 3+) metastatic colorectal cancer who have received two or more prior regimens.

Enhertu, a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by UK pharma major AstraZeneca (LSE: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). AstraZeneca reported first-half 2023 sales for Enhertu of $104 million and alliance revenues of $475 million.

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