FDA expands Xtandi approval for prostate cancer
Click Here to Manage Email Alerts
The FDA expanded the approval of enzalutamide for prostate cancer.
A new indication authorizes use of the agent for men with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (high-risk BCR).
Enzalutamide (Xtandi, Astellas Pharma) is an androgen receptor antagonist.
The FDA based the new indication on results of the randomized EMBARK trial, which included 1,068 patients with nonmetastatic castration-sensitive prostate cancer with high-risk BCR.
All patients received prior definitive therapy with radical prostatectomy and/or radiotherapy with curative intent. All men had PSA doubling time of 9 months or less and were not candidates for salvage radiotherapy.
Researchers randomly assigned men 1:1:1 to blinded enzalutamide 160 mg once daily plus leuprolide, open-label single- agent enzalutamide 160 mg once daily, or blinded placebo once daily plus leuprolide.
Metastasis-free survival assessed by blinded independent central review for enzalutamide-leuprolide vs. placebo-leuprolide served as the major efficacy measure.
The study showed significant improvement in metastasis-free survival with enzalutamide-leuprolide vs. leuprolide-placebo (median not reached in either group, HR = 0.42; 95% CI, 0.3-0.61). Results also showed improved metastasis-free survival with enzalutamide monotherapy vs. placebo-leuprolide (HR = 0.63; 95% CI, 0.46-0.87).
OS data remained immature at the time of data cutoff.
The most common adverse reactions that occurred among at least 20% of patients assigned enzalutamide plus leuprolide included hot flush, musculoskeletal pain, fatigue, fall and hemorrhage. The most common adverse reactions among patients who received enzalutamide monotherapy included fatigue, gynecomastia, musculoskeletal pain, breast tenderness, hot flush, and hemorrhage.
Read more about
Click Here to Manage Email Alerts