LUTATHERA is a drug for the treatment of adults who have a specific type of tumor called a gastroenteropancreatic neuroendocrine tumor (GEP-NET). NETs are rare tumors that develop in certain hormone-producing cells of the body.
LUTATHERA is intended for the treatment of throat, esophagus, stomach, and intestine neuroendocrine tumors that have somatostatin receptors.
Drug Trials Snapshots: LUTATHERA
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 LUTHATERA 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 LUTHATERA Package Insert for complete information.
LUTATHERA (lutetium 177 dotate)
{Lou-Ta-ther-a}
Advanced Accelerator Applications, S.A.
Approval date: January 26, 2018
{Lou-Ta-ther-a}
Advanced Accelerator Applications, S.A.
Approval date: January 26, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
LUTATHERA is a drug for the treatment of adults who have a specific type of tumor called a gastroenteropancreatic neuroendocrine tumor (GEP-NET). NETs are rare tumors that develop in certain hormone-producing cells of the body.
LUTATHERA is intended for the treatment of throat, esophagus, stomach, and intestine neuroendocrine tumors that have somatostatin receptors.
How is this drug used?
LUTATHERA is given by a healthcare provider directly into the bloodstream. This is known as an intravenous or IV infusion. It takes about 30 minutes to receive a LUTATHERA infusion.
LUTATHERA is given once every 8 weeks for a total of 4 doses.
What are the benefits of this drug?
LUTATHERA increased the length of time tumors did not grow after treatment (progression free survival).
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: LUTATHERA worked similarly in men and women.
- Race: Most of the patients were White. Differences in how well the drug worked among races could not be determined because of the small number of patients in other races.
- Age: LUTATHERA worked similarly in patients younger and older than 65 years of age.
What are the possible side effects?
A part of LUTATHERA is radioactive. Treatment with LUTATHERA exposes patients to radiation, and may increase the risk of lifetime radiation exposure.
LUTATHERA may cause serious side effects including low levels of blood cells, abnormal blood cell production (secondary myelodysplastic syndrome), leukemia, kidney or liver injury, increased levels of hormones in the body, (neuroendocrine hormonal crisis), injury to a fetus, and infertility.
The most common side effects of LUTATHERA are nausea, vomiting, tiredness, abdominal pain, 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: Most of the patients were White. Differences in the occurrence of side effects among races could not be determined, because of the small number of patients in other races.
- Age: The occurrence of side effects was similar in patients younger and older than 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved LUTATHERA based primarily on evidence from one clinical trial, NETTER-1 (NCT01578239) of 229 patients with somatostatin-receptor positive midgut GEP-NETs. The trial was conducted at 41 sites in Belgium, France, Germany, Italy, Portugal, Spain, United Kingdom, and the United States.
FDA also considered additional information from a large single-center experience (ERASMUS), in patients with somatostatin-receptor positive GEP-NETs other than those arising from the midgut. The patients were treated in the Netherlands. Demographics of these patients are presented in Table 7, under MORE INFO section.
Figure 1 summarizes how many men and women were enrolled in the clinical trial NETTTER-1 used to evaluate efficacy and safety.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 and Table 1 summarize the percentage of patients by race enrolled in the clinical trial NETTER-1.
Figure 2. Baseline Demographics by Race
1 Race was not collected for 21 patients, in France, due to local regulations
FDA Review
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 188 | 83% |
| Black or African American | 10 | 4% |
| Asian | 1 | less than 1% |
| Other | 9 | 4% |
| Missing1 | 21 | 9% |
1 Race was not collected for 21 patients, in France, due to local regulations
FDA Review
Figure 3 summarizes the percentage of patients by age in the clinical trial NETTER-1.
Figure 3. Baseline Demographics by Age
FDA Review
How were the trials designed?
The benefit and side effects of LUTATHERA were primarily evaluated in one clinical trial, NETTER-1 (NCT01578239). Enrolled patients had tumors which could not be surgically removed and were worsening while receiving treatment with octreotide.
Patients were randomly assigned to receive either LUTATHERA with long-acting octreotide or long-acting octreotide, at a higher dose, alone. LUTATHERA was injected through the vein and long-acting octreotide was injected in the muscle. Both, patients and health care providers knew which treatment was given. The benefit of LUTATHERA was evaluated by measuring the length of time that tumors did not grow after treatment and compared it to the control group (progression free survival).
The FDA considered additional data from a single-center in the Netherlands, ERASMUS. All patients received LUTATHERA with octreotide. Patients and health care providers knew which treatment was given. The benefit of LUTATHERA was evaluated by measuring if and how much the tumor size changed during treatment (the overall response rate).
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.
.png)
No hay comentarios:
Publicar un comentario