Janssen's Erleada receives US FDA approval for non-metastatic prostate cancer treatment

Johnson & Johnson is fighting a patent decision that would open up its older prostate cancer drug Zytiga to early generic competition

Truckee, CA (UroToday.com) FDA has approved apalutamide, the first treatment for nonmetastatic castration-resistant prostate cancer, based on results from a phase 3 study that showed the drug reduced the risk of metastasis or death by 72% and improved median metastasis-free survival by more than 2 years. The study was recently presented at the 2018 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published in The New England Journal of Medicine. "In the trial supporting approval, Erleada had a robust effect on this endpoint".

The approval comes when Johnson & Johnson's blockbuster prostate cancer drug Zytiga is facing challenges.

"As the impact of prostate cancer continues to grow, we are reminded every day of the critical need for therapeutic options that offer patients with prostate cancer more time with their loved ones", added Dr Mark Scholz, executive director of the Prostate Cancer Research Institute.

Patients treated with apalutamide also had a significantly prolonged median time to symptomatic progression, progression-free survival, and time to metastasis, compared with placebo (P .001).

Typically cancer drugs are approved based on their ability to extend survival of patients or halt progression of disease, but the approval of Erleada was based on the drug preventing the cancer from spreading to other parts of the body. A previous study demonstrated that apalutamide prevented elevations of prostate-specific antigen (PSA), a prognostic factor for the development of metastases.

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The FDA has approved Johnson & Johnson's next generation prostate cancer drug, apalutamide in an early but tough to treat form of prostate cancer that has not spread.

The benefit was seen across patient subgroups, including in patients with high rates of disease progression. The primary endpoint was metastasis-free survival.

The green light comes months ahead of the FDA's target review date and is a big boost for J&J, which needs Erleada to hit the ground running and build momentum before Zytiga (abiraterone acetate) - its current blockbuster medicine for CRPC - faces generic competition in the United States, which accounted for around half of the drug's $2.5bn in sales in 2017. Participants were randomly assigned oral Erleada, or placebo, once daily.

The most common Grade 3/4 treatment-emergent adverse events (TEAEs) for ERLEADA in combination with ADT versus placebo in combination with ADT were rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent).

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