Pfizer/Astellas Take Off On New Xtandi Expansion With EMBARK Data

Astellas Has Said This Kind Of Trial Could Be More Challenging Under IRA

Data from the Phase III EMBARK study showed a significant improvement for the drug both in combination with leuprolide and as a monotherapy in reducing risk of metastasis or death in nmHSPC.

Pfizer/Astellas announced data from the Phase III EMBARK trial of Xtandi • Source: Shutterstock

Pfizer Inc. and Astellas Pharma, Inc. will have some more revenue to wring out of the prostate cancer drug Xtandi (enzalutamide) before its anticipated loss of exclusivity (LOE) based on the strength of the Phase III EMBARK trial results in non-metastatic hormone-sensitive prostate cancer (nmHSPC).

The expansion into a larger patient population late in the product’s lifecycle has been identified as the type of R&D...