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FDA grants priority review to apalutamide for certain men with prostate cancer
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The FDA granted priority review to apalutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer, according to the agent’s manufacturer.
There are no FDA-approved treatments for this prostate cancer subtype.
Apalutamide (Janssen) is an oral androgen receptor inhibitor that inhibits the action of testosterone in prostate cancer cells and prevents androgen from binding to the androgen receptor, according to a Janssen-issued press release.
The FDA based the priority review designation on results of the phase 3 ARN-509-003 (SPARTAN) trial, designed to compare apalutamide with placebo for men with nonmetastatic castration-resistant prostate cancer who had rapidly rising PSA levels despite androgen deprivation therapy.
Metastasis-free survival served as the primary endpoint.
Study results will be presented in February at Genitourinary Cancers Symposium.
“The prognosis for men with prostate cancer is significantly worse once the cancer has spread to other parts of the body. Accordingly, men with nonmetastatic castration-resistant prostate cancer need treatment options that can delay disease progression and improve long-term outcomes,” Craig Tendler, MD, vice president of late development and global medical affairs in oncology at Janssen, said in the release. “We are encouraged by the FDA’s recognition, via the priority review designation, of the potential for apalutamide to provide such an option for these men.”
The FDA is scheduled to make a decision on apalutamide’s status for this indication by April.