Erleada (apalutamide)

What is Erleada (apalutamide)?

Erleada (apalutamide) is indicated for the treatment of patients with non-metastatic prostate cancer who no longer respond to medical or surgical hormone treatment that lowers testosterone^[1,2,3,4]. This type of cancer is known as non-metastatic castration-resistant prostate cancer (NM-CRPC)^[1,2,3,4]. Erleada (apalutamide) is the first approved medicine for this disease^[5].

How does Erleada (apalutamide) work?

Erleada (apalutamide) is an androgen receptor (AR) inhibitor, which works by blocking the effect of androgens on the tumour^[1,2,3].

Androgens are hormones that regulate the development of the male sex characteristics^{[6 ]}and are needed for the correct functioning of the prostate^[4]. These hormones, of which testosterone is the most prevalent, work by attaching to androgen receptors (AR) located on both healthy and some cancerous cells^[6]; when androgen binds to its receptor, the receptor sends signals to the cell to grow and divide^[7]. In prostate cancer, this results in the growth of the tumour^[7].

Erleada (apalutamide), as an AR inhibitor, interferes with this mechanism and helps prevent cancer cells from growing^[4].

Where has Erleada (apalutamide) been approved?

Erleada (apalutamide) was approved for non-metastatic castration-resistant prostate cancer by:

• Food and Drug Administration (FDA), USA, on February, 2018^[1]
• Health Canada, Canada, on July, 2018^[2]
• Therapeutic Goods Administration (TGA), Australia, on July 2018^[3], under the name Erlyand.
• European Medicine Agency (EMA), EU, on January 2019^[9]

In November 2018, the European Medicines Agency recommended the granting of a marketing authorisation for Erleada (apalutamide)^[8]. This means that it will be made available in some European countries in the first months of 2019.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Erleada (apalutamide) taken?

The recommended dosage is^[1,2,3]:

• 240 mg (4 60 mg-tablets) taken orally once daily.

Reduction in dose may be required based on symptoms and experienced side effects^[1,2,3].

Complete information about Erleada (apalutamide) dosage and administration can be found in the official prescribing information listed in our references section^[1,2,3].

Note: Please consult with your treating doctor for personalised dosing.

Are there any side effects or adverse reactions of Erleada (apalutamide)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include^[1,2,3]:

• fatigue
• rash
• diarrhoea
• nausea
• vomiting
• hypertension
• arthralgia.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include^[1,2,3]:

• falls and fractures
• seizures.

References

1. Summary of Product Characteristics [FDA]: Erleada (apalutamide)[PDF]

Janssen Biotech, February 2018

2. Product Monograph [Health Canada]: Erleada (apalutamide)[PDF]

Janssen Inc., July 2018

3. Product Information [TGA]: Erlyand (apalutamide)[PDF]

Janssen-Cilag Pty Ltd, July 2018

4. Janssen Biotech, How Erleada works, Last update: October 2018, cited on 21/12/2018
5. FDA News Release: FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint

FDA, February 2018

6. National Cancer Institute, NCI Dictionary of Cancer Terms: androgen receptor, cited on  21/12/2018
7. Nature.com, Androgen receptor: structure, role in prostate cancer and drug discovery, Published in June 2014, cited on 21/12/2018
8. European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) opinion for Erleada, cited on 21/12/2018
9. Summary of Product Characteristics [EMA]: Erleada (apalutamide)[PDF]

Janssen-Cilag International N.V.  January 2019