A new DRUG TRIALS SNAPSHOT is now available
Drug Trial Snapshot: TALZENNA
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 TALZENNA 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 TALZENNA Package Insert for complete information.
TALZENNA (talazoparib)
Tal-ZEN-ah
Pfizer, Inc.
Approval date: October 16, 2018
Tal-ZEN-ah
Pfizer, Inc.
Approval date: October 16, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
TALZENNA is a drug for treatment of adults with a specific form of breast cancer. It is to be used in patients with:
- human epidermal growth factor receptor 2 (HER2)-negative
- an abnormal inherited BRCA gene, and
- whose cancer has spread to other parts of the body (locally advanced or metastatic).
How is this drug used?
TALZENNA capsule is taken once daily
What are the benefits of this drug?
Patients treated with TALZENNA experienced a longer time period before their tumor worsened, in comparison to patients treated with the comparator drug.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: Patients were predominantly women; therefore, sex differences cannot be determined.
- Race: The majority of patients were White. The number of patients of other races was limited; therefore, differences in response among races could not be determined.
- Age: TALZENNA worked similarly in patients above and below 65 years of age.
What are the possible side effects?
TALZENNA may cause serious side effects, including bone marrow suppression and leukemia.
The most common side effects () include tiredness, low blood cell counts, nausea, headache, vomiting, hair loss, diarrhea and decreased appetite.
Were there any differences in side effects among sex, race and age?
- Sex: Patients were predominantly women; therefore, sex differences cannot be determined.
- Race: The majority of patients were White. The number of patients of other races was limited; therefore, differences in side effects among races could not be determined.
- Age: In general, the occurrence of overall side effects was similar in patients above and below 65 years of age.
WHO WAS IN THE STUDIES?
Who participated in the clinical trials?
The FDA approved TALZENNA based on evidence from one clinical trial (NCT01945775) that enrolled patients with HER2-negative locally advanced or metastatic breast cancer.
The trial was conducted at 145 sites in US, Europe, Brazil, South Korea, Taiwan, Israel and Australia.
Figure 1 summarizes how many men and women were enrolled in the clinical trial.
Figure 1a. Baseline Demographics by Sex
FDA Review
Figure 2 and Table 1 summarize enrolled patients by race in the clinical trial.
Figure 2. Baseline Demographics by Race
FDA Review
Table 1. Demographics by Race
Race
|
Number of Patients
|
Percentage
|
|---|---|---|
White
|
300
|
70
|
Asian
|
47
|
11
|
Black or African American
|
13
|
3
|
Other
|
6
|
1
|
Not reported*
|
65
|
15
|
*collection of data not permitted by local regulatory authority
FDA Review
Figure 3 summarizes enrolled 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 evaluated benefits and side effects of TALZENNA in patients with negative locally advanced or metastatic breast cancer. Prior to enrolment, patients received no more than three chemotherapy regimens for their metastatic or locally advanced disease.
In the trial, patients received, at random, either TALZENNA or healthcare provider’s choice of chemotherapy drug. Both, the patients and the health care providers knew which treatment was being given. The treatment continued until the disease progressed or the side effects became too toxic.
The benefit of TALZENNA in comparison to other chemotherapy drug was assessed by the length of time that patients lived without disease progression (progression free survival or PFS).
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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