NERLYNX is a drug for treatment of an early stage HER2 -positive breast cancer in women who have been previously treated with the medicine trastuzumab. NERLYNX is given as an extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back.
Drug Trials Snapshot: NERLYNX
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 NERLYNX 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 NERLYNX Package Insert for complete information.
NERLYNX (neratinib)
(ner links)
Puma Biotechnology, Inc.
Approval date: July 17, 2017
(ner links)
Puma Biotechnology, Inc.
Approval date: July 17, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
NERLYNX is a drug for treatment of an early stage HER2 -positive breast cancer in women who have been previously treated with the medicine trastuzumab. NERLYNX is given as an extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back.
How is this drug used?
Six NERLYNX tablets (total of 240 mg) are taken once a day, with food. NERLYNX is usually taken for 1 year. During the first two months of treatment, patients should also take a drug to manage diarrhea called loperamide, and thereafter as needed.
What are the benefits of this drug?
Women taking NERLYNX experienced a longer time period before their cancer returned, in comparison to women who took placebo.
Information on overall survival of these women is not available at this time.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: The trial included only women therefore sex differences cannot be determined.
- Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in response among races could not be determined.
- Age: NERLYNX worked similarly in patients above and below 60 years of age.
What are the possible side effects?
NERLYNX may cause serious side effects, including severe diarrhea and liver damage.
The most common side effects that occurred in 15% of patients or more include diarrhea, nausea, abdominal pain, tiredness, vomiting and rash.
Were there any differences in side effects among sex, race and age?
- Sex: The trial included only women therefore sex differences cannot be determined.
- Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in side effects among races could not be determined.
- Age: The occurrence of overall side effects was similar in patients 65 years and below and those above 65 years. Certain side effects—called serious adverse events1—were seen more frequently in patients above 65 years. The serious adverse events most frequently reported in this age group were vomiting, diarrhea, kidney failure, and dehydration.
1 Serious adverse event was defined as any event that resulted in one of the following: death, life-threatening event, required hospitalization or extended a current hospital stay, persistent or significant disability/incapacity, cancer, or congenital anomaly or birth defect.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved NERLYNX based on evidence from a clinical trial of 2840 women with HER2-positive, early stage breast cancer who had been previously treated for breast cancer. The trial was conducted in Europe, North America, Asia, South America and Australia.
Figure 1 summarizes how many women were in the clinical trial.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 and Table 1 summarize patients by race in the clinical trial.
Figure 2. Baseline Demographics by Race
Table 1. Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 2300 | 81 |
| Asian | 385 | 13 |
| Black or African American | 74 | 3 |
| Other | 81 | 3 |
FDA Review
Figure 3 summarizes patients by age in the clinical trial.
Figure 3. Baseline Demographics by Age
FDA Review
How were the trials designed?
There was one trial that enrolled women with HER2-positive, early stage breast cancer who have been treated within 2 years with the medicine trastuzumab.
The trial compared patients who were randomly assigned to take either NERLYX or placebo tablets once a day. Neither the patients nor the health care providers knew which treatment was being given until the trials were completed. The treatment continued until the disease returned, the side effects became too toxic, or the patients decided they no longer wanted to participate in the trial.
The trial measured the duration of time in each group before the women’s cancers returned or death occurred.
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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