Pfizer and Astellas' XTANDI has been approved by the US FDA for the early treatment of prostate cancer.

XTANDI becomes the first and only androgen receptor signalling inhibitor approved for use with or without GnRH analogue therapy in non-metastatic castration-sensitive prostate cancer.

This approval follows accelerated FDA development and review programs (Priority Review Designation, Fast Track Designation, Real-time Oncology Review), based on the results of the Phase 3 BARK trial.

XTANDI's approval is a promising therapeutic option for the community, offering a glimmer of hope to patients and their caregivers in these challenging times. said Courtney Bugler, President and CEO of ZERO Prostate Cancer.

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