AZN : Enhertu Granted Breakthrough Therapy Designations In US For Multiple HER2 Expressing Cancers

(RTTNews) - Enhertu or fam-trastuzumab deruxtecan-nxki has been granted two additional Breakthrough Therapy Designations in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, and for the treatment of patients with HER2 positive metastatic colorectal cancer who have received two or more prior regimens, Daiichi Sankyo (DSKYF.PK) and AstraZeneca (AZN,AZN.L) said in a statement on Thursday.

Enhertu is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Enhertu has received seven Breakthrough Therapy Designations and its designation in HER2 expressing metastatic solid tumors represents the first time Enhertu has been granted this designation in a tumor agnostic setting.

Enhertu previously received Breakthrough Therapy Designations for three indications in breast cancer, including HER2 low metastatic breast cancer, second-line HER2 positive metastatic breast cancer and later-line HER2 positive metastatic breast cancer. Two additional Breakthrough Therapy Designations for Enhertu were granted for HER2 mutant metastatic non-small cell lung cancer and HER2 positive metastatic gastric cancer.

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