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FDA grants priority review to Xtandi for metastatic hormone-sensitive prostate cancer
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The FDA has granted priority review to enzalutamide for the treatment of men with metastatic hormone-sensitive prostate cancer, according to a press release from the drug’s manufacturer.
Enzalutamide (Xtandi; Astellas Pharma, Pfizer), an androgen receptor inhibitor, is currently approved for men with castration-resistant prostate cancer.
The FDA granted a supplemental new drug application for the additional indication priority review based on results from two phase 3 trials.
“We are pleased to receive the priority review designation, which reflects the need for more treatment options for men living with metastatic hormone-sensitive prostate cancer,” Chris Boshoff, MD, PhD, chief development officer of oncology at Pfizer Global Product Development, said in a press release. “The submission is supported by a strong data package, including two phase 3 trials investigating Xtandi in men living with this form of prostate cancer.”
The ARCHES trial, results of which were presented at this year’s Genitourinary Cancers Symposium and published in Journal of Clinical Oncology, demonstrated that the addition of enzalutamide to androgen deprivation therapy significantly improved radiographic PFS among men with metastatic hormone-sensitive prostate cancer.
Researchers randomly assigned 1,150 men to 160 mg daily enzalutamide (n = 574) or placebo (n = 576) with ADT. Median radiographic PFS was not reached in the enzalutamide group and was 19.4 months in the placebo group, showing a significant improvement with enzalutamide (HR = 0.39; 95% CI, 0.3-0.5).
Results of the ENZAMET trial, presented during the plenary session at this year’s ASCO Annual Meeting and published in The New England Journal of Medicine, showed that enzalutamide in combination with standard therapy significantly improved OS compared with other nonsteroidal antiandrogen (NSAA) drugs for men with metastatic hormone-sensitive prostate cancer.
The researchers randomly assigned 1,125 men (median age, 69 years) to the standard therapy of testosterone-suppressing drugs — including goserelin (Zoladex; TerSera AstraZeneca), degarelix (Firmagon, Ferring Pharmaceuticals) and leuprolide — in combination with 160 mg oral enzalutamide daily (n = 563) or one of the three standard NSAAs: bicalutamide, nilutamide or flutamide (n = 562).
Results showed that at 3 years, 80% of men who received enzalutamide remained alive compared with 72% of men who received one of the other three NSAAs (HR = 0.67, 95% CI, 0.52-0.86). Overall, men who received enzalutamide had a 33% decreased risk for death compared with men who received other NSAAs.
“The complementary data from the ARCHES and ENZAMET trials in men with [metastatic hormone-sensitive prostate cancer] take us another step closer to understanding Xtandi’s full potential in helping address unmet needs in prostate cancer,” Andrew Krivoshik, MD, PhD, senior vice president and oncology therapeutic area head at Astellas Pharma, said in a press release. “Xtandi is a current standard of care in castration-resistant prostate cancer, and we look forward to working with the FDA to potentially make Xtandi available to men earlier in their prostate cancer journey.”