FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer

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FDA approved abiraterone acetate (Zytiga) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). The drug is sponsored by Janssen Biotech Inc.

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Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”

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