jueves, 3 de diciembre de 2015

Drug Approvals and Databases > Drug Trials Snapshots
YONDELIS

Drug Approvals and Databases > Drug Trials Snapshots<br />YONDELIS



A New DRUG TRIALS SNAPSHOT FOR YONDELIS is now available. YONDELIS is a drug used to treat patients with liposarcoma and leiomyosarcoma that cannot be removed by surgery (unresectable) or is advanced (metastatic). These are rare forms of cancer that begin in fat cells (liposarcoma) or smooth muscle cells (leiomyosarcoma) of the body.

Drug Trials Snapshots provide information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups.

See more Drug Trial Snapshots or contact us with questions at Snapshots@fda.hhs.gov.

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.
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 YONDELIS Prescribing Information for complete information.
YONDELIS (trabectedin)
Yawn-del-iss
Janssen Products, LP
Approval date: October 23, 2015

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

YONDELIS is a drug used to treat patients with liposarcoma and leiomyosarcoma that cannot be removed by surgery (unresectable) or is advanced (metastatic). These are rare forms of cancer that begin in fat cells (liposarcoma) or smooth muscle cells (leiomyosarcoma) of the body.
This treatment is approved for patients who previously received chemotherapy that contained a specific class of drugs called anthracyclines.

How is this drug used?

YONDELIS is given as a continuous infusion over 24 hours into a vein.

What are the benefits of this drug?

Participants who received YONDELIS experienced a delay in the growth of their tumor (called progression-free survival), which occurred on average about 4.2 months after starting treatment, compared to participants assigned to a different drug called dacarbazine. In patients receiving dacarbazine, disease progressed at an average of 1.5 months after starting treatment.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

Subgroup analyses were conducted for sex, race and age.
  • Sex: YONDELIS was similarly effective in men and women.
  • Race: The majority of patients in the trial were white. Differences in response to YONDELIS could not be determined.
  • Age: The majority of patients in the trial were below 65 years of age. Differences in response to YONDELIS could not be determined.

What are the possible side effects?

The most common side effects were nausea, fatigue, vomiting, diarrhea, constipation, decreased appetite, shortness of breath (dyspnea), headache, tissue swelling (peripheral edema), a decrease in infection-fighting white blood cells (neutropenia), low blood platelet counts (thrombocytopenia), low red blood cell count (anemia), elevated liver enzymes, and decreases in albumin, a protein found in blood.
Serious side effects included severe and fatal blood infections, muscle tissue breakdown, liver damage, leakage around the vein or catheter, breakdown of tissue, and heart failure.

Were there any differences in side effects among sex, race and age?

Subgroup analyses were conducted for sex, race and age.
  • Sex:  The risk of side effects was similar in men and women.
  • Race:  The majority of patients in the trial were white. Differences in side effects among races could not be determined.
  • Age: The majority of patients in the trial were below 65 years of age. Differences in side effects between patients below and above 65 years could not be determined.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved YONDELIS based on evidence from a clinical trial of 518 patients with liposarcoma and leiomyosarcoma . The trial was conducted in 85 sites in 4
countries (Australia, Brazil, New Zealand, and the United States). Ninety-four percent of the patients were enrolled in U.S. sites.
Figure 1 summarizes how many men and women were enrolled in the clinical trial.
Figure 1. Baseline Demographics by Sex
Pie chart summarizing how many men and women were enrolled in the clinical trials used to evaluate efficacy of the drug YONDELIS.  In total, 154 men (30%) and 364 women (70%) participated in the clinical trials used to evaluate efficacy of the drug YONDELIS.
Clinical Trial Data
Figure 2 and Table 1 summarize the percentage of patients by race enrolled in the clinical trial.
Figure 2. Baseline Demographics by Race
Pie chart summarizing the percentage of patients by race enrolled in the YONDELIS clinical trial. In total, 394 Whites (76%), 63 Blacks (12%), 19 Asians (4%), 5 American Indian or Alaska Natives (1%), 14 participants that reported Unknown (3%), 18 participants that did not report (3%), and 5 Other (1%) participated in the clinical trial.
Clinical Trial Data
Table 1. Baseline Demographics by Race
RaceNumber of PatientsPercentage
White39476%
Black or African American6312%
Asian194%
American Indian or Alaska Native51%
Other51%
Unknown143%
Not Reported183%
Clinical Trial Data
Figure 3 summarizes the percentage of patients by age group enrolled in the clinical trial.
Figure 3. Baseline Demographics by Age
 Pie chart summarizing how many individuals of certain age groups were enrolled in the YONDELIS clinical trial.  In total, 403 participants were between 17 and 64 years old (78%) and 115 participants were 65 and older (22%).
Clinical Trial Data

How were the trials designed?

In the clinical trial that supported the approval of YONDELIS, participants were randomly assigned to receive either YONDELIS or another chemotherapy drug called dacarbazine every 3 weeks. Treatment continued in both groups until the disease progressed or until there were unacceptable side effects. The trial measured the amount of time from the start of the trial when patients were living with the cancer up until when the cancer worsened (called progression-free survival).

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.

PRESCRIBING INFORMATION

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