Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PROCRIT (Epoetin alfa), epoetin alfa, Epoetin alfa once weekly, Epoetin alfa once every two weeks, Epoetin Alpha, EPO, Epoetin alfa-epbx, Epogen
PROCRIT · 46 trials · 44 indications
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.
First-order absorption rate constant (Ka) estimated using a population pharmacokinetic model. The estimate was derived from plasma erythropoietin concentration data collected at multiple time points following dosing throughout the 28-day study period.
Bioavailability estimated using a population pharmacokinetic target-mediated drug disposition (TMDD) model. Bioavailability represents the fraction of the administered dose reaching the systemic circulation and is reported as a unitless proportion ranging from 0 to 1. The estimate was derived from plasma erythropoietin concentration data collected at multiple time points following dosing throughout the 28-day study period.
Central volume of distribution (Vc) estimated using a population pharmacokinetic target-mediated drug disposition (TMDD) model. The estimate was derived from plasma erythropoietin concentration data collected at multiple time points following dosing throughout the 28-day study period.
Peripheral volume of distribution (Vp) estimated using a population pharmacokinetic target-mediated drug disposition (TMDD) model. The estimate was derived from plasma erythropoietin concentration data collected at multiple time points following dosing throughout the 28-day study period.
| Arm | Type | Description |
|---|---|---|
| Epoetin alfa | EXPERIMENTAL | Group 1: Epoetin alfa type = range unit= IU/Kg number= 337.5 to 1050 IU/Kg form= solution for injection route= subcutaneous use weekly injections (max 40 000 IU per week for first 8 weeks of treatment max 80 000 IU per week later) using pre-filled 1mL 40 000 IU syringes for 24 to 48 weeks |
| No treatment | PLACEBO_COMPARATOR | Group 2: Placebo form= solution for injection route= subcutaneous use weekly injections for 24 to 48 weeks |
| Arm A (lenalidomide) | ACTIVE_COMPARATOR | Patients receive lenalidomide PO QD on days 1-21. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study. |
| Arm B (lenalidomide, epoetin alfa) | EXPERIMENTAL | Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study. |
| 001 | EXPERIMENTAL | epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks |
| 003 | EXPERIMENTAL | epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk |
| 002 | EXPERIMENTAL | epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks |
| Epoetin Alpha study 1 | EXPERIMENTAL | Epoetin Alpha Tthe number of separate doses (per kg) to be given over 4 weeks by day of age will not exceed 10. These will be administered as follows: day of life (DOL) 2 (1200 U), DOL 4 (600 U), DOL 5 (600 U), DOL 6 (600U), DOL 7 (600 U), DOL 9 (600 U), DOL 14 (600 U), DOL 15 (600 U), DOL 16 (1200 U), and DOL 28 (600 U). The greatest dose in any 1 wk period is 3600 U. Infant study 1 Drug Intervention: all infants will be treated with Epoetin Alpha during the first four weeks of life to provide data for determining: 1) the PK/PD model determined optimized Epoetin Alpha dosing schedule; and 2) clinical and laboratory covariates predictive of which infants are good and poor Epoetin Alpha responder. |
| Group 2 | OTHER | Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs). |
| Name | Type | Description |
|---|---|---|
| Group 2: Placebo | DRUG | form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks |
| Group 1: Epoetin alfa | DRUG | type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Epoetin Alfa | BIOLOGICAL | Given SC |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Lenalidomide | DRUG | Given PO |
| Standard supportive care (packed RBC transfusion) | OTHER | Per doctor prescription |
| epoetin alfa + packed RBC transfusion | DRUG | 40,000 IU SC once a week. |
| Epoetin Alpha | DRUG | Infant study 1: VLBW infant study subjects (weighing 1.0 to 1.5 kg at birth) who are otherwise receiving standard clinical care will be treated with Epoetin Alpha according to a dosing algorithm. |
| Standard of care | OTHER | - |
| PROCRIT (Epoetin alfa) | DRUG | - |
Inclusion Criteria: * Diagnosis of MDS according to World Health Organization or French-American-British pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening * Documentation of an International Prognostic Scoring System score indicating Low- or In...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
PROCRIT is used for anemia, a condition in which patients have low red blood cell counts. It is studied in patients receiving chemotherapy, a group at elevated risk of anemia. PROCRIT is developed by Johnson & Johnson and is in Phase 2 clinical development for this indication.
PROCRIT is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is the sponsor of the clinical program evaluating PROCRIT in anemia.
PROCRIT is in Phase 2 clinical development for anemia. It is an investigational therapy and is not described as approved for this use. The Phase 2 trial has been completed, and no active trials are currently listed for PROCRIT.
PROCRIT has been evaluated in one Phase 2 trial, NCT00210600, titled Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy. The trial enrolled 186 patients with anemia, was randomized, and has been completed.
Yes, PROCRIT is also known as Epoetin alfa. PROCRIT (Epoetin alfa) is the full name used for the drug, so searches for either term refer to the same therapy developed by Johnson & Johnson for anemia.