FDA Approves First Treatment for Non-Metastatic CRPC

Last updated: September 2019

The FDA last week approved Erleada (apalutamide) as the first treatment for non-metastatic castration-resistant prostate cancer (CRPC). This provides a new treatment approach for men whose cancer has not spread from their prostate, but continues to grow even after use of standard hormone therapy.1

Apalutamide is an oral tablet licensed to Janssen Pharmaceutical Companies under the brand name Erleada. Erleada is an androgen receptor inhibitor. Androgens, like testosterone, fuel prostate tumor growth and metastases. The drug blocks the effects of androgens on the tumor, thus slowing or stopping the growth of the cancer.

What the research shows

The safety and efficacy of apalutamide was based on the SPARTAN study data. SPARTAN was a randomized clinical trial of 1,207 patients with non-metastatic, castration-resistant prostate cancer. Men in the trial either received apalutamide or a placebo; and all patients were also treated with androgen-deprivation therapy (ADT). Men who received apalutamide had a 72 percent decreased risk of metastasis or death and also had a more than two-year increase in metastasis-free survival compared to men only receiving ADT.2

The most common adverse reactions among men receiving apalutamide in the SPARTAN study were fatigue, high blood pressure, rash, diarrhea, nausea, weight loss, joint pain, falls, hot flush, decreased appetite, fractures and swelling in the limbs. Severe side effects of apalutamide reported in the SPARTAN study include falls, fractures and seizures.1

Important new treatment option

This approval is the first oncology drug reviewed by the FDA to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body.1 It is possible for men to have prostate cancer that is diagnosed as castration-resistant and still so no evidence that the cancer has spread at the time of this diagnosis, which is estimated to be about 16 percent of men with CRPC.

This drug approval represents an important addition to the prostate cancer treatment toolbox. Ninety percent of men with CRPC will eventually develop bone metastases, which can be very painful and lead to bone fractures and spinal cord compression. Metastatic prostate cancer can also involve lymph nodes, lung, and liver. Preventing prostate cancer from spreading is an important treatment goal because prostate cancer that has metastasized increases the risk of death and can significantly impact quality of life.

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