A new DRUG TRIALS SNAPSHOT is now available.
Drug Trials Snapshots: ROZLYTREK
ROZLYTREK is a drug used to treat adult and adolescent patients (12 to 17 years old) whose cancers have a specific genetic feature (biomarker). It is to be used in patients with solid tumors that:
- are caused by certain abnormal NTRK genes and
- have spread or if surgery to remove their cancer is likely to cause severe complications, and
there is no acceptable treatment, or the cancer grew or spread on other treatment
ROZLYTREK is not approved for use in pediatric patients less than 12 years of age.
ROZLYTREK is a capsule taken by mouth once a day
See more Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
ROZLYTREK (entrectinib)
roz lye' trek
Genentech, Inc.
Approval date: August 15, 2019
roz lye' trek
Genentech, Inc.
Approval date: August 15, 2019
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
ROZLYTREK is a drug used to treat adult and adolescent patients (12 to 17 years old) whose cancers have a specific genetic feature (biomarker). It is to be used in patients with solid tumors that:
- are caused by certain abnormal NTRK genes and
- have spread or if surgery to remove their cancer is likely to cause severe complications, and
- there is no acceptable treatment, or the cancer grew or spread on other treatment
ROZLYTREK is not approved for use in pediatric patients less than 12 years of age.
How is this drug used?
ROZLYTREK is a capsule taken by mouth once a day.
What are the benefits of this drug?
Fifty-seven percent of 54 patients with various solid tumors who received ROZLYTREK experienced complete or partial shrinkage of their tumors which lasted for more than 12 months for 45% of them.
ROZLYTREK 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?
The difference in how well the drug worked among sex, race and age groups could not be determined because of the small sample sizes.
What are the possible side effects?
ROZLYTREK may cause serious side effects including congestive heart failure, nervous system problems, bone fractures, liver toxicity, increased uric acid in the blood, heart rhythm problems (because of changes in heart electrical activity called QT prolongation) and vision problems.
The most common side effects of ROZLYTREK are tiredness, constipation, taste changes, body swelling, dizziness, and diarrhea.
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 patients in the clinical trial were White or Asian. Differences in side effects among races could not be determined.
- Age: The majority of patients in the clinical trial were younger than 65 years of age. Differences in side effects between patients below and above 65 years of age could not be determined.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved ROZLYTREK based on the evidence from four clinical trials of 355 patients with various types of solid tumors: Trial 1 (EudraCT 2012-000148-88), Trial 2 (NCT02097810), Trial 3 (NCT02568267), and Trial 4 (NCT02650401). The trials were conducted in the United States, Europe and the Asia/Pacific region.
Subgroup of patients from three trials which provided data for the benefit of ROZLYTREK in treatment of solid tumors (efficacy population) is presented in Table 8 under MORE INFO.
All patients from the four trials who provided data for the side effects of ROZLYTREK (safety population) are presented below.
Figure 1 below summarizes how many patients were in the clinical trials by sex.
Figure 1. Baseline Demographics by Sex (safety population)
Clinical Trial Data
Figure 2 and Table 1 below summarize the percentage of patients in the clinical trials by race.
Figure 2. Baseline Demographics by Race (safety population)
Clinical Trial Data
Table 1. Demographics of Trial by Race (safety population)
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 235 | 66 |
| Black or African American | 16 | 5 |
| Asian | 82 | 23 |
| Not Reported | 22 | 6 |
Clinical Trial Data
Figure 3 below summarizes the percentage of patients in the clinical trials by age.
Figure 3. Baseline Demographics by Age (safety population)
Clinical Trial Data
How were the trials designed?
The benefit of ROZLYTREK was evaluated in three trials and side effects were evaluated in four clinical trials. Most enrolled patients had an unresectable or metastatic solid tumor with abnormal NTRK genes and no satisfactory alternative treatment options, or disease progression following treatment. The most common types of tumors were sarcoma, lung cancer, salivary gland cancer, breast cancer, and thyroid cancer.
Patients received ROZLYTREK until either tumor progression or intolerable side effects.
The benefit of ROZLYTREK was evaluated by measuring the percentage of patients who achieved complete or partial shrinkage of their tumors (overall response rate) and by measuring the duration of that benefit (duration of response).
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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