Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rHuEPO · 3 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| rHuEPO | ACTIVE_COMPARATOR | - |
| Darbepoetin alfa | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| rHuEPO | DRUG | rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12. |
| Darbepoetin alfa | DRUG | 4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11. |
Inclusion Criteria: * Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more * Anemia (hemoglobin \[hgb\] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy * Karnofsky performance status of...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
rHuEPO is an investigational therapy being studied for use in cancer, neoplasms, and pre-dialysis conditions. It is being developed for patients with non-myeloid malignancies and anemia, as well as for those with pre-dialysis end stage renal disease. The drug is currently in Phase 3 clinical development.
rHuEPO is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in oncology and related indications.
rHuEPO is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three Phase 3 trials have been completed, studying the drug in patients with non-myeloid malignancies, anemia, and pre-dialysis end stage renal disease.
rHuEPO has been studied in three completed Phase 3 clinical trials: NCT00038064, titled 'Anemia in Patients With a Non-Myeloid Malignancy,' with 707 participants; NCT00111137, titled 'Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy,' with 718 participants; and NCT00527137, titled 'NESP Pediatric Study,' with 120 participants.
rHuEPO is associated with the name NESP, as indicated by the clinical trial NCT00527137, titled 'NESP Pediatric Study.' This trial evaluates rHuEPO in pediatric patients with pre-dialysis end stage renal disease, suggesting that NESP is an alternative name for the drug.