AstraZeneca, Daiichi notch blockbuster FDA nod for breast cancer med Enhertu

By | December 26, 2019

For metastatic breast cancer patients who try and fail on multiple treatments, 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 despite a shaky safety profile. 

The FDA approved AstraZeneca and Daiichi’s Enhertu (fam-trastuzumab deruxtecan-nxki) on Friday as a treatment for patients with inoperable or metastatic HER2-positive breast cancer who have already failed on at least two other treatments. AstraZeneca and Daiichi will 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 said in a note to investors Monday. At that price, Enhertu could reach $ 68 million in sales in 2020, with a peak sales estimate of $ 2.5 billion, Berens said.

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

RELATED: SABCS: AstraZeneca, Daiichi’s ADC keeps breast cancer at bay for 16 months

Read more on

FiercePharma: Pharma