FDA Approves Zytiga Plus Prednisone for Earlier Form of Metastatic Prostate Cancer

FDA Approves Zytiga Plus Prednisone for Earlier Form of Metastatic Prostate Cancer
Zytiga (abiraterone acetate) is now approved in the U.S. to treat metastatic high-risk castration-sensitive prostate cancer (CSPC) in combination with prednisone, Janssen Pharmaceutical Companies announced. The U.S. Food and Drug Administration (FDA) granted its approval following results of the Phase 3 LATITUDE trial (NCT01715285), which showed that the combo therapy reduced the risk of death by 38 percent in newly diagnosed patients compared to placebo. "LATITUDE was a large global trial which produced impressive and clinically significant results in overall survival," Karim Fizazi, MD, PhD, the study’s lead author, said in a press release. "This milestone is an exciting turning point for researchers and clinicians, and most importantly, for patients suffering from this disease and their families who now have an important additional therapeutic option," added Andree Amelsberg, MD, vice president of oncology medical affairs at Janssen Biotech. LATITUDE was a double-blind clinical trial comparing a once-daily combo of Zytiga plus prednisone with placebo in 1,199 patients with newly diagnosed, metastatic high-risk CSPC, who had not received prior chemotherapy treatment. All patients took a gonadotropin-releasing hormone (GnRH) analog — a medication designed to lower sex hormone levels — or had previous bilateral orchiectomy (removal of the testicles). Investigators defined high-risk disease as having at least two of three risk
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