J&J's Apalutamide, Astellas/Pfizer's Xtandi On Par For Non-Metastatic Prostate Cancer
Phase III data at ASCO GU meeting impress, but raise questions about safety in new non-metastatic CRPC indication – rash, fractures and falls for Erleada (apalutamide) and unexplained deaths after termination of treatment for Xtandi (enzalutamide).
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ASCO GU: Darolutamide is important for the company's oncology portfolio, but does it have enough to compete against J&J's Erleada and Pfizer/Astellas' Xtandi?
Protocol changes for the Phase III ARCHES and EMBARK trials will deliver results in hormone-sensitive prostate cancer a year and a half earlier than expected. Xtandi may then gain a valuable new indication sooner than anticipated, but generics for competitor Zytiga could launch before then.
Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi
The latest drug development news and highlights from our US FDA Performance Tracker.