Pfizer: FDA approval for 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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