What Men Should Know About the FDA's Approval of Erleada

Men with castration-sensitive prostate cancer now have an option for when treatment with androgen deprivation therapy alone is not enough.

Prostate cancer can be difficult to treat once it has spread; however, men with metastatic castration-sensitive prostate cancer now have a treatment option when androgen deprivation therapy (ADT) alone is not enough.

The Food and Drug Administration (FDA) approved Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer — which was reviewed as part of the agency’s Real-Time Oncology Review program designed to have a more efficient review process to make therapies more quickly available to patients.

With this, men with this disease have an option for treatment that was urgently needed, according to Colleen McKenna, vice president of marketing and communications at the Prostate Cancer Foundation.

“Oncologists are always looking to treat earlier and (to treat) truly microscopic metastatic disease with curative intent,” she said in an interview with CURE. “While this is an earlier disease stage than castration-resistant metastatic disease, prostate cancer remains highly incurable once it has fully metastasized, thus, new treatments are urgently needed.”

Standard Treatment

Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate area. It can be controlled by lowering the amount of testosterone in the body, done thought ADT. According to Janssen — the manufacturer of Erleada – approximately 40,000 men in the U.S. are diagnosed with metastatic castration-sensitive prostate cancer annually.

ADT is still the standard of care for these patients, while treatment with abiraterone and docetaxel have shown efficacy in combination with ADT. “However, abiraterone is specifically FDA-approved for men with high-risk metastatic disease, while docetaxel appears effective only in men with high-burden metastatic disease,” McKenna explained.

“For the men with metastatic disease who may not have been appropriate candidates for these treatments, (Erleade plus) ADT may now be considered.”


The approval for Erleada was based on findings from a phase 3 clinical trial that found when patients were given Erleada plus androgen deprivation therapy (ADT), there was a 33% reduction in the risk of death compared with placebo and ADT in the same patient population.

The TITAN trial included 1,052 patients who were newly diagnosed with metastatic castration-sensitive prostate cancer and had prior therapy with docetaxel or localized treatment.

The trial’s researchers also saw a two-year overall survival rate (the length of time from either the date of diagnosis or the start of treatment that patients are still alive) of 82.4% in the group that received Erleada compared with 73.5% in patients receiving ADT alone at 22.7 months follow-up.

Side effects included rash, fatigue, fall, fracture and seizure.

Moving Forward

As this exciting option enters the treatment landscape for certain men with prostate cancer, patients should be aware of certain questions to ask their oncologists. “Men should ask their doctors to discuss all available treatment options for their disease stage, and their possible benefits and side effects, to determine the treatment strategy most likely to be of greatest benefit,” McKenna added.

With this, she noted that the Prostate Cancer Foundation has a variety of resources for men and their caregivers to reference. McKenna is excited about the future of prostate cancer treatment and the foundation’s role in aiding these endeavors.

“The Prostate Cancer Foundation is funding research into many promising new treatment options,” she said. “Clinical trials are underway for promising treatments including precision medicines such as PARP-inhibitors and immunotherapy, as well as a new class of ‘radionuclide’ treatments that deliver radiation directly to tumors.”

Read CURE’s original coverage of the FDA’s approval of Erleada.