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What is Erleada (apalutamide)?

In February of 2018, the United States Food and Drug Administration (FDA) approved the medication Erleada (apalutamide) for the treatment of patients with prostate cancer that hasn’t spread (non-metastatic) which continues to grow even though the patient has had hormone therapy (castration-resistant).1 Erleada was the first medication that was approved for non-metastatic, castration-resistant prostate cancer (NM-CRPC).

Erleada is a tablet that is taken once daily.2 Currently, Erleada comes in 60mg tablets and is dosed at 240mg daily, so patients take 4 tablets daily.

How does Erleada work?

Erleada works by blocking hormones to prevent them from affecting the tumor. These hormones, known as androgens, include testosterone, which can cause the tumor to grow. The medical term for this type of medication is androgen receptor inhibitor. Patients who take Erleada must also take a gonadotropin-releasing hormone (GnRH), or have had a bilateral orchiectomy (removal of the testicles).2

Erleada in clinical trials

Over 1200 patients participated in clinical trials that studied the effectiveness of Erleada.1 In these trials, patients were randomly selected to receive Erleada or a placebo medication. All patients were treated with a hormone therapy, which was either surgical procedure to lower testosterone (surgical castration) or a GnRH. Unlike most trials which base how effective a medication is on how long a patient can be treated without having their cancer progress, Erleada was studied based on how long a patient could be treated before their cancer spread to a different part of the body, otherwise known as metastasis. Erleada was the first drug to be approved based on metastasis-free survival.1

Patients who were treated with Erleada were metastasis-free for an average of about 40 months. Patients who were treated with the placebo were metastasis-free for an average of 16 months.1 The FDA felt that these results were so significant that it granted Erleada priority review, meaning the medication could be approved faster because it had an important impact on the health, safety, and treatment of patients with a serious health condition.

Does Erleada have side effects?

Like any other medication, Erleada can cause side effects in patients who take it. The most common side effects are:3

  • Fatigue, or severe tiredness
  • High blood pressure
  • Rash
  • Diarrhea
  • Nausea
  • Weight loss
  • Joint pains
  • Falls
  • Hot flashes
  • Decreased appetite
  • Fractures
  • Swelling of the legs, hands, and feet

Patients also experienced changes in their lab work including:3

  • Anemia (decreased hemoglobin)
  • Leukopenia (decreased white blood cell count)
  • Lymphopenia (decreased lymphocyte count)
  • Increased cholesterol
  • Increased blood sugars
  • Increased triglycerides
  • Increased potassium levels
  • Decreased thyroid levels

Patients who take Erleada should be aware that they are at an increased risk for falls and fractures.2 These falls were not caused by seizures and were not related to patients fainting or losing consciousness. Two patients on Erleada have reported that they have had seizures.2 If you experience a seizure while taking Erleada, you will have to discontinue the medication permanently.

Talk to your doctor

You should tell your doctor and pharmacist about all of the medications you are on, not just the ones that they prescribe. Your doctor or pharmacist will let you know if any medications you are taking interfere with Erleada.

The FDA estimates that approximately 161,000 men in the United States were diagnosed with prostate cancer in 2017.1 Almost 27,000 men are expected to die from prostate cancer. Erleada offers an effective treatment for NM-CRPC and paves the way for other new prostate cancer treatments.

Last reviewed: October 2019
  1. FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-certain-type-prostate-cancer-using-novel-clinical-trial-endpoint. Published 2019. Accessed September 1, 2019.
  2. Erleada Prescribing Information. Accessdata.fda.gov. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210951s000lbl.pdf. Published 2019. Accessed September 1, 2019.
  3. ERLEADA™ (apalutamide). ERLEADA™ (apalutamide) HCP. https://www.erleadahcp.com. Published 2019. Accessed September 1, 2019.