Overview
Carfilzomib is an injectable antineoplastic agent (IV only). Chemically, it is a modified tetrapeptidyl epoxide and an analog of epoxomicin. It is also a selective proteasome inhibitor. FDA approved carfilzomib in July 2012 for the treatment of adults with relapsed or refractory multiple myeloma as monotherapy or combination therapy.
Background
Carfilzomib is an injectable antineoplastic agent (IV only). Chemically, it is a modified tetrapeptidyl epoxide and an analog of epoxomicin. It is also a selective proteasome inhibitor. FDA approved carfilzomib in July 2012 for the treatment of adults with relapsed or refractory multiple myeloma as monotherapy or combination therapy.
Indication
Carfilzomib is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with lenalidomide and dexamethasone; or dexamethasone; or daratumumab and dexamethasone; or daratumumab and hyaluronidase-fihj and dexamethasone; or isatuximab and dexamethasone. It is also indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
Associated Conditions
- Relapsed/Refractory Multiple Myeloma (RRMM)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/29 | Phase 2 | Not yet recruiting | |||
2025/04/09 | Phase 2 | Not yet recruiting | |||
2025/03/24 | Phase 1 | Not yet recruiting | |||
2025/01/27 | Not Applicable | Recruiting | |||
2024/11/11 | N/A | Recruiting | The First Affiliated Hospital of Soochow University | ||
2024/10/04 | Phase 2 | Recruiting | |||
2024/10/01 | Phase 1 | Recruiting | |||
2024/09/26 | Phase 3 | Recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | ||
2024/05/14 | Phase 3 | Recruiting | |||
2024/05/10 | Phase 4 | Recruiting | The First Affiliated Hospital of Soochow University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Onyx Pharmaceuticals, Inc. | 76075-102 | INTRAVENOUS | 30 mg in 15 mL | 6/30/2022 | |
| Onyx Pharmaceuticals, Inc. | 76075-103 | INTRAVENOUS | 10 mg in 5 mL | 6/30/2022 | |
| Onyx Pharmaceuticals, Inc. | 76075-101 | INTRAVENOUS | 60 mg in 30 mL | 6/30/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/19/2015 | ||
Authorised | 11/19/2015 | ||
Authorised | 11/19/2015 | ||
Authorised | 11/19/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| KYPROLIS POWDER FOR SOLUTION FOR INFUSION 60MG/VIAL | SIN15184P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 60mg/vial | 2/28/2017 | |
| KYPROLIS POWDER FOR SOLUTION FOR INFUSION 30 MG/VIAL | SIN15414P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 30 mg | 1/29/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Carfilzomib for Injection | 国药准字HJ20210054 | 化学药品 | 注射剂 | 7/6/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| KYPROLIS carfilzomib 10 mg powder for injection vial | 288527 | Medicine | A | 2/27/2018 | |
| KYPROLIS carfilzomib 60 mg powder for injection vial | 283228 | Medicine | A | 12/19/2016 | |
| KYPROLIS carfilzomib 30 mg powder for injection vial | 266773 | Medicine | A | 12/19/2016 |