July 5, 2018

For men who no longer respond to hormone therapy…

Health Canada Approves ERLEADA™* (apalutamide tablets), the First Treatment for Men with Non-Metastatic Castration-Resistant Prostate Cancer. ERLEADA™ decreased the risk of metastasis or death in patients by 70 per cent and improved median metastasis-free survival by more than two years.1

SOURCE: Janssen Inc. Press Release

TORONTO, July 4, 2018 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved ERLEADA™ (apalutamide tablets), an oral treatment for patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2ERLEADA™ was granted Priority Review status by Health Canada and is the first treatment approved for men diagnosed with nmCRPC.

Prostate cancer is the most common cancer among Canadian men, with approximately 21,300 men diagnosed in 2017.3 Non-metastatic castration-resistant prostate cancer refers to patients who continue to show disease progression despite androgen deprivation therapy (ADT), and in whom the cancer has not spread to other parts of the body (metastasized).4 Nine out of 10 patients with castration-resistant prostate cancer will ultimately develop bone metastases, which can lead to pain, fractures and spinal cord compression.5 Delaying metastasis is crucial to the treatment of advanced prostate cancer.

Health Canada's approval of ERLEADA™ is based on Phase 3 data from the SPARTAN clinical trial, which showed ERLEADA™ decreased the risk of metastasis or death in nmCRPC patients by 70 per cent and improved median metastasis-free survival by more than two years (difference of 24.8 months) compared to placebo.6

"Previously, men with prostate cancer who were no longer responding to current therapies had to wait until the cancer started to spread before they could go on another treatment," said Dr. Bobby Shayegan, Head, Division of Urology at McMaster University, Hamilton, Ontario, and SPARTAN clinical investigator.** "ERLEADA™ has shown a meaningful delay in the progression to metastases along with a tolerable safety profile. I am excited to have an option I can offer my patients earlier than anything else that has been available."

ERLEADA™ is an orally administered next generation androgen receptor (AR) inhibitor that helps block the activity of androgens (hormones like testosterone) and has been shown to slow the progression of the disease.7 ERLEADA™ is used to treat men with prostate cancer who no longer respond to medical or surgical treatment that lowers testosterone before the cancer has spread to other parts of the body.8

"Until now, men living with this stage of prostate cancer have been forced to wait for their condition to worsen in order to be eligible for the next therapy," said Dr. Stuart Edmonds, Vice President, Research, Health Promotion and Survivorship, Prostate Cancer Canada. "The introduction of drugs to treat non-metastatic castration-resistant prostate cancer provides an important opportunity for these men and their families to maintain their quality of life, by being able to access an approved treatment that can delay disease progression."

Click on this link to access the full press release and SPARTAN trial data

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