AstraZeneca, Daiichi notch blockbuster FDA nod for breast cancer med Enhertu
Enhertu will be co-developed and sold by AstraZeneca and Daiichi, except in Japan where Daiichi owns sole rights. (AstraZeneca)
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.
Understanding the Importance of Crystallization Processes to Avoid Unnecessary Cost, Risk and Development Delays
Wednesday, May 27, 2020 | 10am ET / 7am PT
A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays.