The FDA (US Food and Drug Administration) has recently approved the drug Erleada to treat men with prostate cancer that has not yet spread, but has a quickly rising PSA level while on treatment with hormone therapy, causing a big concern for cancer growth and spread. Erleada is the first FDA-approved treatment for this high-risk type of prostate cancer which is called non-metastatic castration-resistant prostate cancer.
The way Erleada works is that it blocks the effect of androgens, a type of hormone, on the tumor. Research has shown that androgens such as testosterone can help tumors grow.
The FDA based its decision to approve Erleada on a randomized clinical trial of 1,207 men with high-risk non-metastatic, castration-resistant prostate cancer. The trial measured the amount of time that the patients’ tumors did not spread (metastasize). While all of the men in the trial received hormone therapy, only some also received Erleada. The group of men who received Erleada had no metastasis for an average 40.5 months compared to metastasis in 16.2 months for the group of men who did not.
Erleada was approved under the FDA’s new priority review program. This new program is designed to speed up approval of drugs that would significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.
Common side effects of Erleada include high blood pressure, fatigue, diarrhea, rash, nausea, joint pain, weight loss, falls, hot flashes, decreased appetite, fractures and swelling in the limbs. Additional possible side effects could include falls, fractures, and seizures.