MedPath

Carfilzomib

Generic Name
Carfilzomib
Brand Names
Kyprolis
Drug Type
Small Molecule
Chemical Formula
C40H57N5O7
CAS Number
868540-17-4
Unique Ingredient Identifier
72X6E3J5AR

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

HSA Drug Approvals

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

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