ERLEADA is a drug for the treatment of prostate cancer that has not spread to other parts of the body (non-metastatic) and no longer responds to a medical or surgical treatment that lowers testosterone (castration-resistant).
ERLEADA is a tablet. Four tablets (total of 240 mg) are taken once daily with or without food.
Drug Trial Snapshot: Erleada
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the ERLEADA Package Insert for complete information.
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the ERLEADA Package Insert for complete information.
Erleada
(er lee’dah)
Janssen Biotech, Inc.
Approval date: February 14, 2018
(er lee’dah)
Janssen Biotech, Inc.
Approval date: February 14, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
ERLEADA is a drug for the treatment of prostate cancer that has not spread to other parts of the body (non-metastatic) and no longer responds to a medical or surgical treatment that lowers testosterone (castration-resistant).
How is this drug used?
ERLEADA is a tablet. Four tablets (total of 240 mg) are taken once daily with or without food.
What are the benefits of this drug?
In the trial, ERLEADA increased the patients’ survival during which there was no spreading of the cancer (called metastasis-free survival). The median metastasis-free survival for patients taking ERLEADA was 40.5 months compared to 16.2 months for patients taking a placebo.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: All the patients were men since ERLEADA is for the treatment of prostate cancer.
- Race: ERLEADA worked similarly in White, Black or African American, and Asian patients.
- Age: ERLEADA worked similarly in patients below or above 65 years of age, including patients above 75 years of age.
What are the possible side effects?
ERLEADA may cause serious side effects including falls and bone fractures, and seizures.
The most common side effects of ERLEADA include feeling tired, elevated blood pressure, rash, and diarrhea.
Were there any differences in side effects among sex, race and age?
- Sex: All the patients were men since ERLEADA is for the treatment of prostate cancer.
- Race: The occurrence of side effects was similar in White, Black or African American or Asian patients.
- Age: The occurrence of more severe side effects (grade 3-4) in patients treated with ERLADA was higher as age increases.
WHO WAS IN THE STUDIES?
Who participated in the clinical trials?
The FDA approved ERLEADA based on evidence from a clinical trial (NCT01946204) of 1207 patients with prostate cancer that had not spread outside the prostate and that had not responded to castration. The trial was conducted at 332 sites in 26 countries (United States, Canada, several European countries, Israel, Japan, South Korea and Taiwan).
Figures 1, 2, and 3 summarize how many were in the clinical trial by sex, race and age.
Figure 1. Baseline Demographics by Sex
FDA review
Figure 2. Baseline Demographics by Race
FDA Review
Table 1. Demographics by Race
| Number of Patients | Percent | |
|---|---|---|
| Race | ||
| White | 800 | 66 |
| Asian | 140 | 12 |
| Black or African American | 68 | 6 |
| American Indian or Alaska Native | 4 | less than 1 |
| Other | 2 | less than 1 |
| Multiple | 1 | less than 1 |
| Not Reported* | 192 | 16 |
* Data on race and/or ethnicity were not collected in some countries because of local regulations
FDA Review
Figure 3. Baseline Demographics by Age
FDA Review
How were the trials designed?
There was one trial that assessed efficacy and side effects of ERLEADA. Al patients in the trial had a prostate cancer that had not spread outside the prostate and that had not responded to castration. Patients were randomly assigned to receive ERLEADA or placebo. Neither the patient nor the healthcare provider knew which treatment was being given until after the trial was completed. All patients also received either hormone therapy or surgery to lower the amount of testosterone in their body.
The efficacy of ERLEADA was assessed by measuring the length of time that tumor did not spread to other parts of the body or that death occurred after starting treatment. That is called metastasis-free survival (MFS).
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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