A new DRUG TRIALS SNAPSHOT is now available
PADCEV is a drug for the treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. PADCEV may be used in adult patients with urothelial carcinoma:
- · whose cancer has spread (locally advanced or metastatic urothelial carcinoma)
- who have received an immunotherapy drugs (called PD-1 and PDL1 inhibitor)
- · who have received chemotherapy that contains platinum
PADCEV is given by a healthcare professional as an intravenous infusion over 30 minutes on days 1, 8 and 15 of a 28-day treatment cycle. .
See more Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
Drug Trials Snapshots: PADCEV
PADCEV (enfortumab vedotin-ejfv)
PAD-sev
Astellas Pharma
Approval date: December 13, 2019
PAD-sev
Astellas Pharma
Approval date: December 13, 2019
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
PADCEV is a drug for the treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. PADCEV may be used in adult patients with urothelial carcinoma:
- whose cancer has spread (locally advanced or metastatic urothelial carcinoma)
- who have received an immunotherapy drugs (called PD-1 and PDL1 inhibitor)
- who have received chemotherapy that contains platinum
How is this drug used?
PADCEV is given by a healthcare professional as an intravenous infusion over 30 minutes on days 1, 8 and 15 of a 28-day treatment cycle.
What are the benefits of this drug?
Forty four percent of 125 patients who received PADCEV experienced complete or partial shrinkage of their tumors which lasted about 7.6 months.
PADCEV 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.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: PADCEV worked similarly in men and women.
- Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in how well PADCEV worked in other races could not be determined.
- Age: PADCEV worked similarly in patents younger and older than 65 years of age.
What are the possible side effects?
PADCEV may cause a serious side effects including high blood sugar, damage to peripheral nerves (peripheral neuropathy), eye disorders, skin reactions and infusion site reactions. Other serious side effects include possible harm to an unborn baby.
The most common side effects of PADCEV include rash, fatigue, decreased appetite, hair loss, taste change, peripheral neuropathy, nausea, diarrhea and dry skin.
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: The majority of patients were White. The number of patients in other races was limited; therefore, differences in the occurrence of side effects among other races could not be determined.
- Age: The occurrence of side effects was similar in patents younger and older than 65 years of age.
WHO WAS IN THE STUDIES?
Who participated in the clinical trials?
The FDA approved PADCEV based on evidence from one clinical trial (NCT03219333) of 125 adults with urothelial carcinoma (a type of bladder or urinary tract cancer). The trial was conducted at 40 sites in the United States and Japan.
Figure 1 summarizes how many men and women were in the clinical trial.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 summarizes the percentage of patients by race in the clinical trial.
Figure 2. Baseline Demographics by Race
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 PADCEV were evaluated in one clinical trial. Enrolled patients had bladder and urinary tract cancer that had spread after receiving treatment with PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. All patients received PADCEV infusion over 30 minutes on days 1, 8 and 15 of every 28-day cycle until either the disease worsened, or they developed an unacceptable side effect.
The benefit of PADCEV was evaluated by counting the patients who experienced partial or complete tumor shrinkage.
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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