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FDA expands Zytiga approval for prostate cancer
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The FDA expanded the approval of abiraterone acetate to include its use in combination with prednisone for treatment of men with metastatic high-risk, castration sensitive prostate cancer, according to the agent’s manufacturer.
Abiraterone (Zytiga, Janssen Oncology), an adrenal inhibitor, already had been approved for use in combination with prednisone for treatment of metastatic castration-resistant prostate cancer.
The FDA based the expanded approval on results of the randomized, phase 3 LATITUDE trial.
The multicenter, double-blind, placebo-controlled trial included 1,199 men with newly diagnosed metastatic high-risk, castration-sensitive prostate cancer who had not received prior cytotoxic chemotherapy.
Criteria for high-risk disease included at least two of the following factors at baseline: three or more lesions on bone scan, Gleason score of 8 or higher, and evidence of visceral metastases. Investigators excluded patients with significant adrenal, cardiac or hepatic dysfunction.
Researchers randomly assigned 597 patients to 1,000 mg daily abiraterone plus 5 mg daily prednisone. The other 602 patients received placebo. All patients received a gonadotropin-releasing hormone analog or had prior bilateral orchiectomy.
As HemOnc Today previously reported, results showed the combination reduced the risk for death by 38% (median OS, not estimable vs. 34.7 months; HR = 0.62; 95% CI, 0.51-0.76).
The combination also appeared associated with significant delay in time to initiation of chemotherapy (median, not reached vs. 38.9 months; HR = 0.44; 95% CI, 0.35-0.56).
“LATITUDE was a large global trial [that] produced impressive and clinically significant results in overall survival,” Karim Fizazi, MD, PhD, principal investigator and head of the medical oncology department at Institute Gustave Roussy in France, said in a Janssen-issued press release. “With today’s approval, abiraterone acetate plus prednisone could become a standard of care for patients with metastatic high-risk castration-sensitive prostate cancer.”
The most common adverse events among patients in the LATITUDE trial treated with the combination were fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flushes, diarrhea, vomiting, upper respiratory infection, cough and headache.
Andree Amelsberg, M D, vice president of oncology medical affairs at Janssen Biotech Inc., said the expanded approval is “an important step in addressing the unmet needs” of patients with metastatic high-risk, castration-sensitive prostate cancer.
“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,” Amelsberg said in the release.