Published: Sun, February 18, 2018
Health | By Jay Jacobs

J&J gets quick approval for new next-gen prostate cancer drug

J&J gets quick approval for new next-gen prostate cancer drug

The FDA approved the new-generation androgen receptor inhibitor apalutamide (Erleada) for treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC).

Erleada's approval comes just at the right time for J&J, as analysts have already said that it could achieve sales north of a billion dollars in a slightly different indication from Zytiga.

Median metastasis-free survival among patients in the apalutamide arm was 40.5 months, compared with 16.2 months in the placebo arm.

"Delaying the metastasis of prostate cancer is critical".

The approval was supported by data from the Phase 3 SPARTAN study involving 1,207 patients with non-metastatic, castration-resistant prostate cancer.

For the SPARTAN phase 3 study, researchers randomly assigned 1207 men characterized as high-risk for developing metastases who had a PSA doubling time for 10 months or less to receive apalutamide 250 mg daily or placebo; all patients continued ADT throughout the study.

Prostate cancer is the second most common type of cancer in men, according to the National Cancer Institute (NCI) at the National Institutes of Health.

Earlier this month, data from a study testing Xtandi showed that use of the drug in early stage prostate cancer on top of standard hormone therapy reduced the risk of the disease spreading or death by 71 percent compared with hormone therapy alone. MFS benefit was consistently seen across all subgroups of patients.

The drug, approved ahead of its April user fee action date, will be sold under the trade name Erleada. The median TTM was 40.51 months for ERLEADA compared to 16.59 months for placebo (HR=0.27; 95% CI, 0.22-0.34; P 0.0001) and the median PFS was 40.51 months compared to 14.72 months for placebo (HR=0.29; 95% CI, 0.24-0.36; P 0.0001).

Erleada also led to statistically significant improvements in several other measures, including time to metastasis, time to disease progression or death, and time to symptomatic progression. "Almost 90 percent of patients with castration-resistant prostate cancer will eventually develop bone metastases, at which point the prognosis sharply worsens", Mathai Mammen, MD, PhD, global head of Johnson & Johnson subsidiary Janssen Research & Development, said in a press release.

"Treatment with apalutamide was generally well tolerated, with no impact on quality of life scores and with low rates of discontinuation due to treatment-related adverse events", Dr Small said.

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