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fosnetupitant/ palonosetron · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Test group | EXPERIMENTAL | intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination, administered as a 30-minute infusion of a 50 mL solution, on Day 1 of each cycle. Oral dexamethasone will be administered on Day 1 of each cycle (12 mg) |
| Control group | ACTIVE_COMPARATOR | oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle. Oral dexamethasone will be administered on Day 1 of each cycle (12 mg) |
| Name | Type | Description |
|---|---|---|
| fosnetupitant/ palonosetron | DRUG | intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination |
| netupitant/palonosetron | DRUG | oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination |
| dexamethasone | DRUG | Oral dexamethasone (12 mg) |
Inclusion Criteria: Cycle 1: The following inclusion criteria must be checked prior to inclusion at Cycle 1: 1. Patient read, understood and signed the written informed consent before any study related activity, agreeing to participate in the study and to comply with study requirements. 2. Female...
Fosnetupitant/palonosetron is an investigational small molecule combination being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV). It is administered intravenously and is being studied in patients receiving chemotherapy, specifically in women with breast cancer undergoing AC chemotherapy.
Fosnetupitant/palonosetron is being developed by Healthcare Services Group, which trades under the ticker HCSG. The company is conducting clinical development of this intravenous combination for the prevention of chemotherapy-induced nausea and vomiting.
Fosnetupitant/palonosetron is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under investigation for its intended use.
Fosnetupitant/palonosetron has been studied in one completed Phase 3 trial, NCT03403712. This randomized, double-blind, active-controlled study enrolled 404 women with breast cancer to compare intravenous fosnetupitant/palonosetron (260 mg/0.25 mg) with oral netupitant/palonosetron (300 mg/0.5 mg) for preventing chemotherapy-induced nausea and vomiting.
Fosnetupitant/palonosetron is a distinct intravenous formulation of the combination, while netupitant/palonosetron is the oral version. In clinical trials, the intravenous form (260 mg/0.25 mg) has been compared directly against the oral form (300 mg/0.5 mg) for the prevention of chemotherapy-induced nausea and vomiting.