The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the US prescribing information for Xtandi (enzalutamide) capsules to include new clinical data from the TERRAIN trial (ClinicalTrials.gov Identifier: NCT01288911), which compared enzalutamide with bicalutamide among patients with metastatic castration-resistant prostate cancer (CRPC).1
The updated product label now includes data that show enzalutamide reduces the risk of radiographic progression or death by 40% vs bicalutamide (hazard ratio, 0.60; 95% CI, 0.43-0.83). Median radiographic progression-free survival was 19.5 months with enzalutamide compared with 13.4 months with bicalutamide.
“The addition of data from the TERRAIN trial continues to build the body of evidence that demonstrates the clinical impact XTANDI can have for patients living with metastatic CRPC,” Steven Benner, MD, senior vice president, therapeutic area head for oncology development, Astellas, said in a statement.
The safety profile of enzalutamide was consistent with previous reports. Those occurring more frequently with enzalutamide than with bicalutamide were fatigue, back pain, and hot flush.
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For the double-blind, phase 2 study, investigators enrolled 375 asymptomatic or minimally symptomatic men with prostate cancer progression on androgen deprivation therapy. Participants were randomly assigned 1:1 to receive enzalutamide or bicalutamide.
“We are pleased with the FDA’s decision to update the XTANDI label with these data from the first and largest comparative trial that demonstrated safety and efficacy of enzalutamide compared to bicalutamide,” Mohammad Hirmand, MD, interim chief medical officer of Medivation, Inc., said in a press release. “We believe these data will help physicians better understand the differences between enzalutamide and bicalutamide for their patients living with metastatic CRPC.”
- FDA approves supplemental New Drug Application for Xtandi in advanced prostate cancer. Astellas website. https://www.astellas.com/en/corporate/news/detail/fda-approves-supplemental-new-.html. Updated October 21, 2016. Accessed October 24, 2016.