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FDA grants priority review to Xtandi for prostate cancer subtype

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The FDA granted priority review to a supplemental new drug application for enzalutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer, according to the agent’s manufacturer.

Enzalutamide (Xtandi; Astellas, Medivation) — an androgen receptor inhibitor — is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

The FDA based this designation on results from the phase 3 PROSPER trial, which evaluated the addition of enzalutamide to androgen deprivation therapy among 1,401 patients with nonmetastatic castration-resistant prostate cancer.

As HemOnc Today previously reported, researchers presented results at the Genitourinary Cancers Symposium.

Results showed enzalutamide plus ADT significantly reduced the risk for developing metastasis or death compared with ADT alone.

Researchers observed more adverse events in the combination arm (87% vs. 77%), which were consistent with those reported in previous trials.

“Treatment options have been limited for men with nonmetastatic castration-resistant prostate cancer, in whom the only evidence of progressive disease is a rapidly rising PSA,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer Global Product Development, said in a company-issued press release. “Xtandi is already established as a standard of care for men with metastatic castration-resistant prostate cancer. This milestone marks an important step toward our ability to bring Xtandi to castration-resistant prostate cancer patients in an earlier setting.”