LATITUDE Trial Leads to New Approval for Abiraterone
Abiraterone (brand name Zytiga) is an oral drug that interrupts androgen production in the testes, the adrenal glands, and in prostate tumors. Abiraterone is taken in combination with the steroid prednisone.
The LATITUDE trial assessed the use of abiraterone for men with various stages of advanced prostate cancer. Phase 3 results from the study found that abiraterone reduced the risk of death by 38% for patients with metastatic, high-risk castration- sensitive prostate cancer when compared to placebo. Abiraterone use also significantly delayed the time when men in the study began chemotherapy.
Based on these results, in February the U.S. Food and Drug Administration (FDA) approved a new indication for abiraterone; the drug is now approved for use in patients newly diagnosed with metastatic hormone- sensitive prostate cancer. This means that patients can now take abiraterone in an earlier stage of prostate cancer in conjunction with hormone therapy. The drug was previously approved for use in patients with metastatic castration-resistant prostate cancer.
Metastatic castration-sensitive prostate cancer still responds to androgen-deprivation therapy (ADT, also known as hormone therapy). Metastatic castration-resistant prostate cancer no longer responds to ADT.
N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.