MedPath

Olaratumab

Generic Name
Olaratumab
Brand Names
Lartruvo
Drug Type
Biotech
CAS Number
1024603-93-7
Unique Ingredient Identifier
TT6HN20MVF

Overview

Olaratumab (IMC-3G3) is a fully human IgG1 monoclonal antibody with antitumor activity that selectively binds the external domain of human platelet-derived growth factor receptor (PDGFR)-α with high affinity and blocks ligand binding. It is composed of two heavy chain molecule fragments and 2 light chain fragments. Studies show that the treatment of olaratumab in combination with doxorubicin resulted in significant reduction of cancer cell proliferation and tumor growth. Olaratumab was granted accelerated approval (as Lartruvo) as initial therapy to treat adults with certain types of soft tissue sarcoma (STS) in October, 2016.

Indication

用于治疗软组织肉瘤。

Associated Conditions

  • Soft Tissue Sarcoma

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2019/06/21
N/A
APPROVED_FOR_MARKETING
2019/06/14
Phase 1
Active, not recruiting
Grupo Espanol de Investigacion en Sarcomas
2018/10/05
Phase 2
Terminated
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
2018/02/19
Phase 1
Withdrawn
2017/09/14
Phase 1
Completed
2017/04/24
Phase 1
Completed
2017/03/22
Phase 1
Completed
2016/05/26
Phase 1
Completed
2016/02/09
Phase 1
Completed
2016/01/20
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
LARTRUVO
eli lilly canada inc
02480271
Solution - Intravenous
190 MG / 19 ML
6/9/2020
LARTRUVO
eli lilly canada inc
02469227
Solution - Intravenous
500 MG / 50 ML
12/22/2017

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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