FDA approves abiraterone acetate for treatment of castration-sensitive, metastatic prostate cancer


Late yesterday the US Food and Drug Administration announced the approval of abiraterone acetate (Zytiga) + prednisone for the treatment of men with “high-risk, castration-sensitive”, metastatic prostate cancer.

This expands the use of the combination of standard ADT + abiraterone acetate + prednisone from the treatment of chemotherapy-naive mCRPC to the treatment of at least “high-risk” ADT-sensitive prostate cancer based on the data from the LATITUDE trial, as reported at the annual meeting of the American Society of Clinical Oncology earlier this year (see here) and then published in the New England Journal of Medicine back in July.

Many physicians — and probably many patients too — would argue that any patient with metastatic prostate cancer is at “high risk”. However, the patients enrolled in the LATITUDE trial were required to meet all of the following criteria:

  • Newly diagnosed with “hormone naive” (i.e., “castration-sensitive”), metastatic prostate cancer, documented with a positive bone scan or CT scan or MRI
  • 18 or more years of age
  • A ECOG performance score of 0, 1, or 2, and
  • Two out of three of the following “high-risk” factors
    • A Gleason score of ≥ 8
    • Three or more evident lesions on their bone scan
    • Evident visceral metastasis

So these are the new set of patients whose disease is considered by the FDA to be suitable for treatment with ADT + abiraterone acetate + prednisone.

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