44. Enhertu

AstraZeneca manufacturing employee

Active ingredient: fam-trastuzumab deruxtecan-nxki
Disease: HER2-positive breast cancer
Peak sales estimate: $2.5 billion
Approved: Dec. 20, 2019
Companies: AstraZeneca/Daiichi Sankyo 

The scoop: For metastatic breast cancer patients for whom multiple treatments have failed, finding options to manage disease is a difficult proposition. AstraZeneca and Daiichi Sankyo hoped their antibody-drug conjugate could help that tough-to-treat population—and the FDA agreed to give it a shot in late December despite a shaky safety profile. The FDA approved AstraZeneca and Daiichi's Enhertu (fam-trastuzumab deruxtecan-nxki) as a treatment for patients with inoperable or metastatic HER2-positive breast cancer for whom at least two other treatments have already failed. AstraZeneca and Daiichi plan to jointly develop and sell the drug outside of Japan, where Daiichi holds exclusive rights. Enhertu will likely launch in January at a per-patient cost of around $13,300 per month, SVB Leerink analyst Andrew Berens, M.D., said in a note to investors. At that price, Enhertu could reach $68 million in sales in 2020, with a peak sales estimate of $2.5 billion, Berens said. –– Kyle Blankenship 

44. Enhertu

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