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Enzalutamide (ENZALU) Granted New Indication: Castration-Sensitive Prostate Cancer

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Qualifying and interested individuals participated in the clinical trial of enzalutamide for
metastatic castration-sensitive prostate cancer (mCSPC). This led to the FDA approval of
enzalutamide (ENZALU, Arechar Healthcare LLP) on December 16, 2019.
Previously, enzalutamide was approved for use in patients with castration-resistant prostate
cancer.
“With this approval, men with prostate cancer now have a new treatment option. Being a part of
an innovation-driven pharmaceutical firm, it is exciting to see such vital approvals that address
unmet patient needs.” Anindya Bhalla, Medical Oncologist
This exemplifies an interesting turn towards the treatment of every variation of advanced
prostate cancer. To determine and investigate the efficacy, a trial namely ARCHES
(NCT02677896) was undertaken. It comprised 1150 patients with metastatic castration-
sensitive prostate cancer randomized (1:1). Those individuals received either enzalutamide
orally in the strength of 160 mg or (N=574) or placebo orally once daily (N=576). It was assured
that all patients received either a GnRH analog or have had prior surgery (bilateral orchiectomy).
The measure of efficacy outcome was rPFS (radiographic Progression-Free Survival). With
regard to the blinded independent central review, this was the total time starting from
randomization to radiographic disease progression at any moment or death within 2 years post-
drug continuation. Besides that, the additional endpoint was time for a new antineoplastic
agent.
In comparison with 19.4 months (95% CI: 16.6, NR) in the placebo arm (HR 0.39; 95% CI: 0.30,
0.50, the median rPFS did not reach in the enzalutamide arm. As per the statistics, a significant
improvement was noted on the enzalutamide arm when compared to the placebo in time to

initiation of a different antineoplastic medicine (HR 0.28; 95% CI: 0.20, 0.40; p<0.0001). Plus, the
overall survival data were not determined during rPFS analysis.
The dose-related adverse reactions (≥ 5%) that were more commonly
experienced by patients in ARCHES (≥ 2% over placebo) during enzalutamide
treatment were asthenia/fatigue, hot flushes, musculoskeletal pain,
hypertension, and fractures.
The recommended dose of Enzalutamide (ENZALU) is 160 mg once daily. Administered orally
with/without food.
View full prescribing information for ENZALU.

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