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FDA approved Nubeqa (darolutamide) for Non-Metastatic Castration-Resistant and Metastatic Castration-Sensitive Prostate CancerFDA approved Nubeqa for Two Types of Advanced Prostate Cancer

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Key Takeaway
Note: Nubeqa 600 mg twice daily with food; adjust to 300 mg twice daily in severe renal or moderate hepatic impairment.

The FDA has approved Nubeqa (darolutamide) for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), including mCSPC in combination with docetaxel. Darolutamide is an androgen receptor inhibitor.

The recommended dose is 600 mg (two 300 mg tablets) taken orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone (GnRH) agonist or antagonist concurrently or have had a bilateral orchiectomy. When used with docetaxel for mCSPC, the first of 6 docetaxel cycles should be administered within 6 weeks after starting Nubeqa. Treatment continues until disease progression or unacceptable toxicity.

The approval in nmCRPC was supported by the ARAMIS trial, a double-blind, placebo-controlled study in 1,509 patients with a prostate-specific antigen doubling time of 10 months or less. The primary endpoint was metastasis-free survival. Trial data for the mCSPC indications are not available in the label.

+ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Darolutamide is an androgen receptor inhibitor.

Indication & Patient Population

Nubeqa is indicated for the treatment of adult patients with: - non-metastatic castration-resistant prostate cancer (nmCRPC) - metastatic castration-sensitive prostate cancer (mCSPC) - metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel

Dosing & Administration

Recommended dosage: 600 mg (two 300 mg tablets) orally twice daily, swallowed whole, with food. Continue until disease progression or unacceptable toxicity. Patients should also receive a GnRH agonist or antagonist concurrently or have had bilateral orchiectomy. For mCSPC with docetaxel, administer the first of 6 docetaxel cycles within 6 weeks after starting Nubeqa. Missed doses should be taken as soon as remembered prior to the next scheduled dose; do not take two doses together.

Dosage modification: For greater than or equal to Grade 3 or intolerable adverse reactions, withhold Nubeqa or reduce to 300 mg twice daily until symptoms improve. May resume 600 mg twice daily when adverse reaction returns to baseline. Dosage reduction below 300 mg twice daily is not recommended. Additional modifications may be required for ischemic heart disease or seizure.

Severe renal impairment (eGFR 15-29 mL/min/1.73 m2) not on hemodialysis: 300 mg twice daily. Moderate hepatic impairment (Child-Pugh Class B): 300 mg twice daily.

Key Clinical Trial Data

ARAMIS (NCT02200614) was a multicenter, double-blind, placebo-controlled trial in 1,509 patients with nmCRPC and PSADT of 10 months or less. Patients were randomized 2:1 to Nubeqa 600 mg twice daily (n=955) or placebo (n=554). All received a GnRH analog or had bilateral orchiectomy. Median age was 74 years; 9% were 85 years or older. Racial distribution: 79% White, 13% Asian, 3% Black or African American; 3.1% Hispanic or Latino. Median PSADT was 4.5 months. The primary endpoint was metastasis-free survival (MFS), defined as time from randomization to first evidence of BICR-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan. Overall survival, time to pain progression, and time to initiation of cytotoxic chemotherapy were additional endpoints. Trial data for mCSPC indications are not available in the label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Nubeqa is an oral androgen receptor inhibitor for adults with nmCRPC or mCSPC. It is used with concurrent GnRH therapy or after bilateral orchiectomy. For mCSPC, it may be used alone or in combination with docetaxel. Treatment continues until disease progression or unacceptable toxicity.

Nubeqa is a new pill approved by the FDA to treat two types of advanced prostate cancer in adults. One type is non-metastatic castration-resistant prostate cancer, which means the cancer has not spread to other parts of the body but is no longer controlled by standard hormone therapy. The other type is metastatic castration-sensitive prostate cancer, which means the cancer has spread but still responds to hormone therapy. For this second type, Nubeqa can be used alone or with a chemotherapy drug called docetaxel.

The drug works by blocking the action of male hormones that can fuel prostate cancer growth. It is taken as two tablets twice a day with food. Patients must also receive a hormone therapy shot or have had surgery to remove the testicles. When used with docetaxel, the first chemotherapy cycle should start within six weeks of beginning Nubeqa. Treatment continues until the cancer worsens or side effects become too hard to manage.

The approval for the non-metastatic type was based on a large study that showed a delay in cancer spread. Data for the metastatic type are not yet available in the drug label. This approval gives patients and doctors another treatment choice, but it is not a cure. Every patient is different, so talk with your doctor about whether Nubeqa is right for you.

What this means for you:
Nubeqa is a new pill for two types of advanced prostate cancer, but ask your doctor if it fits your situation.

Study Details

Study typeFda approval
PublishedJul 2019
View Original Abstract ↓
1 INDICATIONS AND USAGE NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
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