FDA NewsPerspective

FDA approves Erleada, first treatment for prostate cancer subtype

The FDA approved apalutamide for the treatment of patients with nonmetastatic, castration-resistant prostate cancer.

Apalutamide (Erleada, Janssen) inhibits the action of testosterone in prostate cancer cells and prevents androgen from binding to the androgen receptor.

The FDA based this approval on results from a randomized clinical trial of 1,207 patients with nonmetastatic, castration-resistant prostate cancer, who were randomly assigned apalutamide or placebo. All patients received treatment with either gonadotropin-releasing hormone analog therapy or surgical castration.

Results of this study were presented at the Genitourinary Cancer Symposium earlier this month.

As HemOnc Today previously reported, metastasis-free survival was 40.5 months for patients assigned apalutamide compared with 16.2 months for patients assigned placebo.

“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,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”

Common side effects of apalutamide included fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flush, decreased appetite, fractures and peripheral edema. Severe side effects included falls, fractures and seizures.

Apalutamide previously received priority review.

The FDA approved apalutamide for the treatment of patients with nonmetastatic, castration-resistant prostate cancer.

Apalutamide (Erleada, Janssen) inhibits the action of testosterone in prostate cancer cells and prevents androgen from binding to the androgen receptor.

The FDA based this approval on results from a randomized clinical trial of 1,207 patients with nonmetastatic, castration-resistant prostate cancer, who were randomly assigned apalutamide or placebo. All patients received treatment with either gonadotropin-releasing hormone analog therapy or surgical castration.

Results of this study were presented at the Genitourinary Cancer Symposium earlier this month.

As HemOnc Today previously reported, metastasis-free survival was 40.5 months for patients assigned apalutamide compared with 16.2 months for patients assigned placebo.

“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,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”

Common side effects of apalutamide included fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flush, decreased appetite, fractures and peripheral edema. Severe side effects included falls, fractures and seizures.

Apalutamide previously received priority review.

    Perspective
    Wm. Kevin Kelly

    Wm. Kevin Kelly

    In the past, there was no therapy indicated for men with nonmetastatic, or M0, castrate-resistant prostate cancer and apalutamide is the first FDA-approved treatment for this disease state. There is a 2.5-times improvement in median metastasis-free survival among men receiving apalutamide compared with placebo. Although well tolerated, there was a higher rate of rash, hypothyroidism and fractures associated with the use of apalutamide, so an appropriate discussion of these risk and benefits needs to be discussed with the patient and, along with monitoring, preventing and managing any toxicities. 

    • Wm. Kevin Kelly, DO
    • Sidney Kimmel Cancer Center at Jefferson Health

    Disclosures: Kelly reports no relevant financial disclosures.