Apalutamide Submitted for FDA Approval in Prostate Cancer

Excerpt:

“Janssen Biotech has submitted a new drug application to the FDA for apalutamide (ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), the manufacturer of the next-generation oral androgen receptor inhibitor announced today.

“Apalutamide inhibits the action of testosterone in prostate cancer cells and prevents androgen from binding to the androgen receptor. Currently, there are no FDA-approved treatments for patients with nonmetastatic CRPC, Janssen noted in a press release.”

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Second-Generation AR-Targeting Agent Explored in High-Risk Prostate Cancer

Excerpt:

“Researchers are hoping the results of a late-stage efficacy and safety study of apalutamide (ARN-509) in patients with high-risk, localized, or locally advanced prostate cancer who are receiving primary radiation therapy will demonstrate an improvement in metastasis-free survival, according to global principal investigator, Howard M. Sandler, MD.

“ ‘The patient population that we’re studying are men who are at risk of dying of prostate cancer,’ Sandler, chair of the Department of Radiation Oncology at Cedars-Sinai Medical Center in Los Angeles, told OncologyLive. ‘If we can provide better upfront disease control, we’re hoping to reduce the number of men who enter into the castrate-resistant prostate cancer stage.’ “

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