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ARTICLE | Company News

Efficacy data set trastuzumab ADC up for fast approval for third-line breast cancer

December 21, 2019 12:41 AM UTC

Less than two weeks after establishing a new threshold for efficacy in HER2+ breast cancer, Enhertu fam-trastuzumab deruxtecan-nxki has gained accelerated approval from FDA in the indication a mere two months after receiving Priority Review. The therapy is the focus of a multibillion-dollar deal between Daiichi and AstraZeneca.

The agency approved the anti-HER2 mAb linked to a TOPI inhibitor, which had a PDUFA date in 2Q20, to treat unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2 treatments...