AstraZeneca, Daiichi Sankyo get FDA nod for breast cancer drug

Dec. 23, 2019

AstraZeneca and its Japan-based partner Daiichi Sankyo announced that the FDA has granted accelerated approval to their antibody drug conjugate candidate, Enhertu, for metatstaic breast cancer.

After impressive clinical trial results, the approval for Enhertu came much earlier than anticipated The FDA had granted priority review to the biologics license application seeking approval for Enhertu in October, and a decision was not expected until the second quarter of 2020.

The drug will be available as monotherapy for unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2 based regimens in the metastatic setting.

AstraZeneca acquired joint development and commercialization rights to this promising cancer candidate from Japan’s Daiichi Sankyo in April this year for approximately $6.9 billion.

Read the press release