Apalutamide (Erleada) was approved based on metastasis-free survival, which is a new clinical endpoint.
Today, the FDA approved apalutamide (Erleada) for the treatment of patients with non-metastatic, castration-resistant prostate cancer, according to a press release.
Apalutamide is the first drug approved for non-metastatic, castration-resistant prostate cancer.
“In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public,” said Richard Pazdur, MD, director of the Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research.
The National Cancer Institute estimates that up to 20% of prostate cancers are castration-resistant and up to 16% of patients do not display evidence of metastasis until they are diagnosed as castration-resistant.
Apalutamide is an oral androgen receptor inhibitor that blocks the effect of androgens, such as testosterone, which are known to contribute to tumor growth.
The safety and efficacy of apalutamide was explored in a trial that included 1207 patients with non-metastatic, castration-resistant prostate cancer.
Patients were randomized to receive apalutamide or placebo in addition to a gonadotropin-releasing hormone analog or surgical castration.
The researchers discovered that the median metastasis-free survival for patients treated with apalutamide was 40.5 months compared with 16.2 months for those treated with placebo, according to the release.
The FDA noted that the approval was granted based on the novel clinical trial endpoint of metastasis-free survival.
“The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs,” Dr Pazdur said. “This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment.”
The FDA advised that common adverse events associated with apalutamide include fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flushes, decreased appetite, fractures, and peripheral edema.
The application previously received priority review designation, according to the release.