What Men With Prostate Cancer Should Know About the FDA's Approval of Nubeqa

Men with non-metastatic castration-resistant prostate cancer now have an earlier more precise treatment option, according to Dr. Jonathan W. Simons.

Over 73,000 men are estimated to be diagnosed with castration-resistant prostate cancer this year alone in the US, according to a press release issued by Bayer — the agent’s manufacturer. With the Food and Drug Administration (FDA)’s approval of Nubeqa (darolutamide) to treat these patients, there are now more options sooner for a group who previously were limited.

“When (patients with non-metastatic castration-resistant prostate) cancer have relapsed from their treatment with radiation or surgery, because of microscopic metastatic disease — their disease has come back but we do not know where it has spread – we’ve generally, in the past, waited to see the cancer on scans before we instituted hormonal therapy,” explained Simons, who is president and chief executive officer at the Prostate Cancer Foundation, in an interview with CURE.

“But this study proves that in appropriately checked and selected patients, (oncologists) can start treating as soon as the prostate-specific antigen (PSA) blood test is abnormal prior to seeing the disease on any scans. So, it is an earlier effective treatment,” he said, adding that this approval has led to a shift in the paradigm of how oncologists will treat those with a rising PSA.

PSA Levels

Approximately 40% of men with prostate cancer have a type of disease that has not spread to other parts of the body and is also associated with a rising PSA level, despite a castrate testosterone level, which is known as non-metastatic castration-resistant prostate cancer.

However, within two years, one-third of these patients will go on to develop metastases, a secondary malignant growth at a distance from the primary site of cancer — which is where PSA monitoring is important.

PSA levels can be a good indicator of how effective treatment is or has been and is an important tool to monitor an individual’s cancer. However, if a patient’s PSA levels have risen following treatment with surgery or radiation, physicians may not be able to determine where the disease has metastasized or spread.

Now, regardless of this, patients have a treatment option: “Just because we can’t see the cancer doesn’t mean we can’t treat the cancer that we know is active,” Simons said.

“It is a historic thing because we now know, scientifically, we can extend the lives of patients by treating earlier with more precise drugs,” he added. “To treat metastatic prostate cancer earlier with better drugs, this FDA approval is a validation of all of that.”

FDA’s Approval

The agency based its approval on data from the randomized, double-blind, placebo-controlled, multi-center phase 3 ARAMIS trial — designed to evaluate Nubeqa, an androgen receptor inhibitor, plus androgen deprivation therapy in 1,509 patients with non-metastatic castration-resistant prostate cancer.

The trial showed a significant improvement in metastasis-free survival — the measure of time from diagnosis or treatment to appearance of a distant metastasis (cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes). The median metastasis-free survival was 40.4 months compared with 18.4 months for placebo plus androgen deprivation therapy.

The most frequent side effects included fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%) In the Nubeqa and placebo arms, respectively.

The FDA approved Nubeqa under priority review — which is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions – three months ahead of its target action date.