A new DRUG TRIALS SNAPSHOT is now available.
IMFINZI is a drug for the treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. IMFINZI may be used when:
- cancer has spread (locally advanced or metastatic urothelial carcinoma) and,
- chemotherapy that contains platinum did not work or is no longer working.
IMFINZI was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.
Drug Trials Snapshots: IMFINZI
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 IMFINZI Prescribing Information 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 IMFINZI Prescribing Information for complete information.
IMFINZI (durvalumab)
im-FIN-zee
AstraZeneca Pharmaceuticals
Approval date: May 1, 2017
im-FIN-zee
AstraZeneca Pharmaceuticals
Approval date: May 1, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
IMFINZI is a drug for the treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. IMFINZI may be used when:
- cancer has spread (locally advanced or metastatic urothelial carcinoma) and,
- chemotherapy that contains platinum did not work or is no longer working.
IMFINZI was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.
How is this drug used?
IMFINZI is given every two weeks by a healthcare provider using a needle placed in a vein (known as intravenous infusion). It takes about 60 minutes to receive the full dose of IMFINZI.
What are the benefits of this drug?
Seventeen percent of 182 patients who were treated with IMFINZI responded to the treatment with complete or partial shrinkage of their cancer. Forty-five percent of responding patients maintained their response for more than 6 months and some for 12 months or longer.
More trials are ongoing to confirm the clinical benefit of IMFINZI.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: IMFINZI worked similarly in men and women.
- Race: Majority of the patients was White; therefore differences in response to IMFINZI among races could not be determined.
- Age: IMFINZI worked similarly in patients below and above 65 years of age.
What are the possible side effects?
IMFINZI can cause immune system to attack normal organs and tissues which may lead to serious side effects including inflammation of the lungs, liver, colon, kidneys and endocrine glands. IMFINZI may cause serious or life threatening infusion reactions and infections.
The most common side effects of IMFINZI are tiredness, muscle or bone pain, constipation, decreased appetite, nausea, swelling of the limbs, and urinary tract infection.
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in men and women.
- Race: Majority of the patients was White; therefore the differences in side effects among races could not be determined.
- Age: The occurrence of side effects was similar in patients below and above 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved IMFINZI based on evidence from one clinical trial of 182 patients with advanced bladder and urinary tract cancer. The trial was conducted in the United States, Canada and Europe.
The figure below summarizes how many men and women were in the clinical trial.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trial.
Figure 2. Baseline Demographics by Race
FDA Review
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 117 | 64 |
| Asian | 36 | 20 |
| Black or African American | 6 | 3 |
| Other | 6 | 3 |
| Missing | 17 | 9 |
FDA Review
Figure 3 summarizes the percentage of patients by age in the clinical trial.
Figure 3. Baseline Demographics by Age
FDA Review
How were the trials designed?
The benefit and side effects of IMFINZI were evaluated in one clinical trial of patients with advanced bladder and urinary tract cancer. Patients’ cancer had progressed while receiving or after they received a platinum-based therapy.
In the trial, all patients received treatment with IMFINZI every 2 weeks. The treatment continued for up to 12 months or until either the disease worsened or the patient developed an unacceptable side effect.
The benefit of IMFINZI was evaluated after 12 months by measuring how well the patients responded to IMFINZI and by how long that response lasted.
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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