NUBEQA To Treat Advanced Stage Prostate Cancer

“NUBEQA, or darolutamide, is the fourth in a list of novel hormonal agents — or second generation androgen receptor directed therapies that we now have in the market,” says Dr. David Wise, medical oncologist, cancer researcher and director of urologic medical oncology at NYU Langone Perlmutter Cancer Center.

“It really was developed in a very specific way,” Dr. Wise explains to SurvivorNet. “And the most recent approval, which has really led to its incorporation into the standard of care for many men, is its incorporation into the triplet therapy paradigm for men who are diagnosed with metastatic hormone sensitive prostate cancer.”

When is NUBEQA Used in Advanced Prostate Cancer Treatment?

Dr. Wise continues to describe the specificities that warrant the use of NUBEQA, which was first approved by the Food and Drug Administration (FDA) in July 2019 for non-metastatic castration-resistant prostate cancer (when cancer has not spread but is no longer responding to hormone therapy), and then subsequently approved for use in the following specific metastatic cases in August 2022.

“At the time of initial diagnosis, if a man has more than four bone metastases with one outside the spine or pelvic area or with metastasis in the lung or liver, and the oncologist believes that these men need chemotherapy and hormonal suppression, we now have data that these men should not be treated with just those two medications, or that doublet,” Dr. Wise says.

“The chemo hormonal therapy doublet should not be the standard anymore. It should always be a triplet of chemotherapy plus hormonal suppression plus NUBEQA.”

NUBEQA is Only Used When Advanced Prostate Cancer Patients Require Chemotherapy

Dr. Wise clarifies that not all men with metastatic hormone sensitive prostate cancer need chemotherapy. In many instances, there are men who don’t.

“There are many men with low volume disease who are asymptomatic,” he says, meaning that they are not showing symptoms, or who “have a minimal burden of disease.”

Additionally, men who are older “and more frail and may really have their quality of life unnecessarily diminished with chemotherapy” may opt to forego chemo, or rather, their doctors may advise them to forego that treatment.

“If the oncologist deems that that patient should be treated with hormonal suppression, the most common of which is leoprolide or relogolix, and docetaxel, which is chemotherapy, then that man should also be treated with maintenance darolutamide, NUBEQA.”

NUBEQA Has Shown Improved Side Effects in Trials Compared to Other Therapies

Though NUBEQA has shown “a similar side effect profile” compared to the “other next generation hormonal therapies,” according to Dr. Wise, those side effects were shown to have “an impressive improvement” during trials.

“So that’s really been the big change,” he says. “Probably the most talked about — is the lower rates of fatigue and mental fog that are observed with darolutamide (NUBEQA), at least based on the trials that were reported in non-metastatic but hormone resistant prostate cancer, where we did see an impressive improvement relative to hormonal suppression alone.”

“To be fair, there have not been large head-to-head studies comparing the different hormone medicines to really prove the differences in fatigue or cognitive problems with darolutamide (NUBEQA) versus the others,” Dr. Wise adds.

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