Health Canada has approved Erleada (apalutamide tablets) to treat patients with non-metastatic castration-resistant prostate cancer (i.e., those patients with prostate cancer who show disease progression despite androgen deprivation therapy (ADT) although the cancer has not spread to other parts of the body). If this type of cancer is not treated properly, the cancer will eventually metastasize and until now, there were no treatment options available to these patients that would attenuate disease progression.

The drug approval was based on Phase 3 SPARTAN clinical trial involving over 1200 men with non-metastatic castration-resistant prostate cancer given Erleada (240 mg/day; n=806) or placebo (n=401). The study observed a median metastasis-free survival of 40.5 months in the Erleada-treated group compared with 16.2 months in the placebo group (P < .001). The most common adverse events observed with Erleada inlcude fatigue, hypertension, rash, diarrhea, nausea, weight loss, joint pain and falls.

In a news release, Bobby Shayegan, MD, Head of Urology at McMaster University said, “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. Shayegan, added, “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.”

Stuart Edmonds, PhD, of Prostate Cancer Canada noted, “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.”

Interestingly, the drug was evaluated using a pilot work-sharing initiative between Health Canada and Australia’s Therapeutic Goods Administration (TGA).

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Smith MR, Saad F, Chowdhury S, et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018;378:1408-1418
DOI: 10.1056/NEJMoa1715546