The recently approved Nubeqa (darolutamide) is intended to prevent the spread of prostate cancer and keep men in specific stages of the disease symptom-free for longer.
In the United States, an estimated 174,650 new cases of prostate cancer will be diagnosed in 2019, and about 31,620 men will die from this disease, according to the
Prostate cancer is the second-leading cause of death from cancer in U.S. men.
On July 30, the Food and Drug Administration (FDA) approved a new treatment option from Bayer and Finnish drug company Orion for men experiencing an advanced stage of this cancer called non-metastatic castration-resistant prostate cancer (nmCRPC).
The new drug is called Nubeqa (darolutamide), and it could more than double how long a man survives the disease without it spreading further in the body.
Male hormones (androgens) can worsen prostate cancer and cause it to spread (metastasize). Nubeqa is an androgen receptor inhibitor (ARi) intended to prevent this from happening.
“Prostate cancer, especially one that’s spread to other parts of the body, is remarkably male-hormone sensitive to proliferation when it’s exposed to testosterone and testosterone metabolites like
Dr. Shore explained that FDA approval was based on a phase III ARAMIS trial that showed Nubeqa increased what’s known as metastasis-free survival (MFS).
MFS is used as a predictor of overall survival for this specific form of prostate cancer. Trial participants using Nubeqa experienced an MFS of 40.4 months on average, compared to only 18.4 months for those given a placebo.
The results of the trial were published earlier this year in the New England Journal of Medicine.
The ARAMIS trial was a randomized, phase III, multi-center, double-blind, placebo-controlled trial to evaluate the safety and efficacy of oral Nubeqa in men with nmCRPC being treated with androgen deprivation therapy (ADT) who are at high risk for developing metastatic disease.
It involved 1,509 participants who were randomized to receive 600 milligrams (mg) of the oral drug twice a day, or a placebo, along with ADT.
“With the approval of Nubeqa, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men with nmCRPC,” Robert LaCaze, member of the executive committee of the pharmaceuticals division and head of the oncology strategic business unit at Bayer, said in a statement.
“Patients at this stage of prostate cancer [MFS] typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy,” Matthew Smith, MD, PhD, director of the genitourinary malignancies program at Massachusetts General Hospital Cancer Center in Boston, said in a statement.
“This approval marks an important new option for the prostate cancer community,” he said.
Nubeqa was approved under the Agency’s
“In early trials, we saw that the drug is remarkably well-tolerated, and the type of events unique to ARis like apalutamide and enzalutamide that we’ve seen in other phase III trials, such as cognitive impairment, falls, fractures, and fatigue, aren’t seen with darolutamide,” Shore said.
However, he added that the reactions that did occur most often in those given Nubeqa included:
- fatigue
- pain in the extremities
- rash
“The cost of Nubeqa takes into account the clinical outcomes for patients and low side effect profile. The wholesale acquisition cost (WAC) of Nubeqa is $11,550 for a 30-day supply of 300-mg tablets,” Bayer said in an emailed statement to Healthline.
Cost can be an issue for many people, but Bayer also said they’re committed to ensuring that men in the United States who are prescribed Nubeqa will be able to access this medication and receive the support they need.
The company is launching a patient support program called Darolutamide User Drug Experience (DUDE) Access Services, which provides a free, two-month trial to eligible men and $0 co-pay for those who qualify and are commercially insured.
To learn more about these and other services, visit the website or call 1-833-337-DUDE (1-833-337-3833) Monday through Friday from 9:00 a.m. to 7:00 p.m. (EST).
Prostate cancer is the second leading cause of death from cancer in U.S. men. Nubeqa is a recently FDA-approved drug said to significantly increase how long men survive without the disease spreading to other parts of the body.
While this oral drug is effective, there are possible side effects that include fatigue, rash, and pain in the extremities.
Bayer is committed to making the drug available to men who need it, and has launched a patient support and $0 copay program that may help.