Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EP2006 · 1 trial · 2 indications
Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5\*10\^9 cells/L)
| Arm | Type | Description |
|---|---|---|
| EP2006 | EXPERIMENTAL | Eligible patients will be teated with EP2006 |
| Filgrastim | ACTIVE_COMPARATOR | Eligible patients will be teated with Filgrastim |
| Name | Type | Description |
|---|---|---|
| EP2006 | DRUG | Eligible patients will be teated with EP2006 |
| Filgrastim | DRUG | Eligible patients will be teated with Filgrastim |
Inclusion Criteria: 1. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy 2. Women ≥ 18 years of age 3. Estimated life expectancy of more than six months Exclusion Criteria: 1. Previous or concurrent malignancy except non-invasive...
EP2006 is an investigational small molecule being developed for chemotherapy associated neutropenia, a condition of low white blood cell counts that can occur after cancer treatment. It is being studied in patients with breast cancer undergoing chemotherapy. The drug is currently in Phase 3 clinical development.
EP2006 is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its ability to address chemotherapy associated neutropenia, a condition marked by low neutrophil counts that can increase infection risk during cancer treatment.
EP2006 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with chemotherapy associated neutropenia.
EP2006 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, active-controlled study. The drug is not yet approved and remains investigational, meaning it is still being evaluated for safety and efficacy in clinical trials.
EP2006 has one completed Phase 3 clinical trial registered under NCT01519700. This study compared the efficacy and safety of EP2006 with filgrastim in 218 female patients with breast cancer and chemotherapy associated neutropenia. The trial was conducted across multiple countries, including Czechia, Hungary, Latvia, Russia, Slovakia, and Ukraine.
EP2006 is not the same as filgrastim, but it was studied as a potential alternative to it. In the Phase 3 trial NCT01519700, EP2006 was compared directly against filgrastim, which is an established treatment for chemotherapy associated neutropenia. The trial was active-controlled, meaning filgrastim served as the comparator.