Johnson & Johnson on Wednesday announced that the FDA approved Erleada (apalutamide) as the first drug cleared in the US for use in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The company's submission of the next-generation androgen receptor inhibitor was granted priority review by the agency last December, with a target date of April this year.
According to the FDA, the approval was based on safety and efficacy data from the Phase III SPARTAN trial, which randomised 1207 patients with nmCRPC to receive either Erleada or placebo. Results from the study, which were unveiled earlier this month, showed that Erleada significantly improved median metastasis-free survival by 2 years versus placebo in men with nmCRPC, cutting the risk of distant metastasis or death by 72 percent compared to placebo.
Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, remarked "this approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumours did not spread to other parts of the body or that death occurred after starting treatment," continuing "this demonstrates the agency's commitment to using novel endpoints to expedite important therapies to the American public."
FirstWord reports in this therapy area - KOL Insight Prostate Cancer: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
According to Guggenheim Securities analyst Tony Butler, the list price of Erleada is expected to be $10 920 for a bottle of 120 tablets per month, which is priced at a slight premium to Johnson & Johnson's Zytiga (abiraterone acetate). Zytiga generated global sales of $2.5 billion last year, but is set to face generic competition. "We could see the Zytiga patent case proceed to trial around mid-year," Wells Fargo analyst Lawrence Biegelsen noted, suggesting that generic competition is unlikely until the second-half of 2018.
The approval of Erleada also comes shortly after Pfizer and Astellas released late-stage data illustrating that Xtandi (enzalutamide) in combination with androgen deprivation therapy (ADT) cut the risk of metastasis or death by a significant 71 percent in patients with nmCRPC versus ADT alone (for additional analysis, see KOL Views: Can apalutamide and/or Xtandi change non-metastatic CRPC practice patterns? For further analysis on Erleada, read also ViewPoints: Johnson & Johnson says more about apalutamide while still staying mum).
In addition, the FDA noted Wednesday that Johnson & Johnson is the first participant in its recently announced pilot programme to assess whether the release of certain information within clinical study reports (CSRs) following new drug approvals would improve public access to approval information. The agency said that shortly after the authorisation, specific CSR information will be posted on its Drugs@FDA website as well as the new pilot programme landing page.
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