Second 'Breakthrough' designation for Enhertu, now in gastric cancer

11 May 2020

Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted a second Breakthrough Therapy designation (BTD) in the USA, this time for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

The drug is partnered by Japan’s Daiichi Sankyo (TYO: 4568) and UK-based AstraZeneca (LSE: AZN), who entered into a global collaboration in March 2019, to jointly develop and commercialize Enhertu worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights.

Daiichi Sankyo, whose shares were down 1.48% at 7,635 yen by close of market today, is solely responsible for manufacturing and supply. AstraZeneca was up 1% in early-afternoon trading. The British company paid an upfront $1.35 billion for the rights under a deal that could be worth nearly $7 billion to Daiichi Sankyo.

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