If you have prostate cancer, your health care provider may have told you about a medicine called Nubeqa (darolutamide).
The FDA approved Nubeqa in 2019. It is commonly used to treat prostate cancer along with a treatment that lowers testosterone.
Testosterone is an androgen hormone that can help fuel the growth of prostate cancer. Treatments that lower testosterone, including certain medicines and surgeries, are often used to treat prostate cancer. But over time, as the cancer learns how to grow despite very low testosterone levels, these treatments may not work as well.
Nubeqa works to block the effects of testosterone from reaching cancer cells. It belongs to a class of medicines called androgen receptor blockers, also known as anti-androgens. Nubeqa is a newer medicine in this class and is considered a second-generation anti-androgen.
Below are common questions and answers about Nubeqa for prostate cancer.
Is Nubeqa Right for Me?
Your health care provider will likely do testing to check the type of prostate cancer you have and whether it has spread outside of the prostate. The results, along with your past medical history, can help your health care team find out if Nubeqa is right for you. Nubeqa is FDA-approved to treat the following types of prostate cancer in adults:
- Prostate cancer that has not spread outside of the prostate (non-metastatic) and no longer responds to treatment that lowers testosterone. This type of prostate cancer is called non-metastatic castration-resistant prostate cancer, or nmCRPC for short.
- Prostate cancer that has spread to other areas of the body (metastatic) and still responds to treatment that lowers testosterone. This is called metastatic castration-sensitive prostate cancer, or mCSPC. For this type of prostate cancer, Nubeqa is commonly used along with a chemotherapy medicine called docetaxel.
“Castration” refers to either a surgery that removes the testicles (the main source of testosterone) or a medicine that lowers testosterone by reducing how much your body makes.
Unless you have had castration surgery, your health care provider will likely prescribe Nubeqa along with a medicine that lowers testosterone. Common examples are goserelin (Zoladex) and leuprolide (Lupron Depot).
Even if your prostate cancer no longer responds to a medicine that lowers testosterone, it is important to continue using it to keep your testosterone levels low. Keep using it as prescribed while taking Nubeqa.
How Does Nubeqa Work for Prostate Cancer?
Androgen hormones, such as testosterone, can help prostate cancer cells grow. Nubeqa works by blocking certain receptors (binding sites) so that androgens cannot attach to them. This blocks the effect of testosterone from reaching cancer cells, which can help slow the growth of prostate cancer and may shrink tumors in some cases.
Nubeqa belongs to a class of medicines called androgen receptor blockers, also known as anti-androgens. Some examples of medicines in this class that have been around for a long time are bicalutamide (Casodex) and flutamide (Eulexin). Nubeqa is a newer, second-generation anti-androgen. These newer medicines are generally better at slowing the spread of prostate cancer and can help people live longer – even if an older anti-androgen medicine was not helpful for them.
How Do I Take Nubeqa?
Nubeqa is available as an oral tablet. It comes in one strength of 300 milligrams (mg).
The recommended dosage of Nubeqa is 600 mg twice daily. Each dose of 600 mg is taken as two 300-mg tablets, swallowed whole and with food. Taking Nubeqa with food helps your body absorb more of the medicine, which helps it work effectively.
How Was Nubeqa Studied for Prostate Cancer?
Two clinical studies were done to test how well Nubeqa works for prostate cancer by comparing its effects to a placebo (a “fake” pill that contains no medicine). Both studies also looked at the safety of Nubeqa by collecting information about side effects compared to a placebo.
The ARAMIS study tested the effect of Nubeqa in adult males whose prostate cancer had not spread outside the prostate and no longer responded to a treatment that lowered testosterone. This is called non-metastatic castration-resistant prostate cancer (nmCRPC). Most of the people who entered this study already tried an anti-androgen medicine, such as bicalutamide, in the past. About two-thirds of the people in the study were randomly chosen to take Nubeqa, while the rest took a placebo.
Another study, called ARASENS, tested the effect of Nubeqa in adult males whose prostate cancer had spread to other areas of the body but was still responding to a treatment that lowered testosterone. This is called metastatic castration-sensitive prostate cancer (mCSPC). About half of the people in the study were randomly chosen to take Nubeqa, while the rest took a placebo. Everyone in the study also received treatment with docetaxel, a chemotherapy medicine.
The median ages of people in both studies were 67-74 years, meaning that half were younger and half were older. The ages ranged from 41 to 95 years. About 52%-79% of the people in the studies were White, 13%-36% were Asian, and 3%-4% were Black or African American. About 3%-7% of the people were Hispanic or Latino.
During the studies, no one knew if the pill they were given was Nubeqa or a placebo. Everyone in both studies also received a medicine to lower testosterone, unless they had surgery for this purpose.
What Are the Main Benefits of Nubeqa, Based on Studies?
The main benefit of Nubeqa is that it can help people live longer without their prostate cancer spreading or getting worse. Results from the two clinical studies showed that Nubeqa worked better than a placebo for treating prostate cancer, along with a treatment that lowers testosterone. Some of the main results of these studies are described below.
The ARAMIS study aimed to measure how well Nubeqa treated non-metastatic castration-resistant prostate cancer (nmCRPC), which is prostate cancer that has not spread and no longer responds to treatment that lowers testosterone. The main goal of the study was to see if Nubeqa could delay the cancer from spreading. To measure this, the people in the study had check-ups and scans every four months to check for the spread of cancer. The researchers kept track of how long people lived without their cancer spreading, known as metastasis-free survival. (Note that this measures how long the cancer took to progress, not overall survival.) The results of the ARAMIS study were as follows:
- People who took Nubeqa went a median of 22 months longer without their cancer spreading. This means that half of the people had their cancer progress before this time frame, and half after.
- Half of the people who took Nubeqa did not have their cancer spread for at least three years (40.4 months), compared to a median of 18.4 months for those who took a placebo.
- The study found that the risk of cancer spreading was reduced by 59% for those taking Nubeqa.
The ARASENS study looked at how well Nubeqa treated metastatic castration-sensitive prostate cancer (mCSPC), which is prostate cancer that has spread to other areas of the body and still responds to a treatment that lowers testosterone. The main goal of the study was to see if the combination of Nubeqa/chemotherapy worked better than placebo/chemotherapy, which was measured by how long people lived, known as overall survival. The results of the ARASENS study were as follows:
- Nubeqa helped people live longer than a placebo. The study found that taking Nubeqa reduced the risk of death by 32.5%.
- After four years, about 63% of the people taking Nubeqa were still alive, compared to about 50% of the placebo group.
Keep in mind that everyone in both studies also received a treatment to lower testosterone (either a medicine or a surgery). Your results may be different from what was seen in studies.
What Types of Drug Interactions Can Happen With Nubeqa?
Several medicines can interact with Nubeqa. Interactions may decrease how well Nubeqa works or increase your risk of side effects.
Some medicines that speed up (induce) both a protein called P-glycoprotein (P-gp) and an enzyme called CYP3A4 could make Nubeqa less effective. The maker of Nubeqa recommends avoiding these types of medicines while taking Nubeqa. Ask your health care provider if any of your current medicines fall into this category and, if so, if they can see if there is another option that would not interact. One example is an antibiotic called rifampin.
Other medicines that block (inhibit) both P-gp and CYP3A4 can raise the blood levels of Nubeqa in your system. One example is itraconazole, a medicine for fungal infections. This type of interaction may increase the chance of side effects from Nubeqa or could make its side effects more severe. Ask your health care provider if any of your current medicines fall into this category. If so, they may monitor you more closely for any side effects and, if necessary, adjust your dosage of Nubeqa.
Nubeqa can also affect how other medicines work. For example, it can raise the blood levels of medicines that are transported in the body by proteins called BCRP or OATP. This can increase the risk of side effects from those medications. Your health care provider may monitor you more closely for any side effects and, if necessary, adjust the dose of these other medicines.
To help identify and manage drug interactions, be sure to talk to your prescriber about all the medicines, vitamins, and supplements you are taking.
When Should I Stop Taking Nubeqa?
Nubeqa is meant to be a long-term treatment. Most people take it for as long as it is safe and effective for them. Your health care provider will tell you how long to take Nubeqa. They may stop your treatment if it causes you bothersome or severe side effects or if your cancer gets worse.
How Can I Get Nubeqa?
Nubeqa requires a prescription from a health care provider. Your prescriber may provide you with a sample pack of Nubeqa, which includes enough medicine for the first month of treatment. Your local pharmacy is unlikely to have Nubeqa. Instead, your health care provider will send your prescription to a specialty pharmacy. They will arrange with you to ship the medicine to your home.
Is There Any Cost Assistance Available?
A cost assistance program is available from Bayer HealthCare Pharmaceuticals, the maker of Nubeqa. It may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured.
For more information about Nubeqa costs and copay savings, visit www.nubeqa-us.com/savings-support/patient-assistance. You can also call the drugmaker at 800-288-8374 to connect with a representative for financial support information and other resources.
