Olaratumab
PDGF-R α | |
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Clinical data | |
Trade names | Lartruvo |
Other names | IMC-3G3, LY-3012207 |
AHFS/Drugs.com | Monograph |
License data | |
Intravenous infusion | |
ATC code | |
Legal status | |
Legal status | |
Proteolytic enzymes | |
Elimination half-life | 11 days |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
Chemical and physical data | |
Formula | C6554H10076N1736O2048S40 |
Molar mass | 147241.21 g·mol−1 |
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Olaratumab, sold under the brand name Lartruvo, is a
It was removed from the United States and European Union markets in 2019, due to insufficient proof of its medical advantage (see below "Medical uses").
Medical uses
Olaratumab is used in combination with
In a
Contraindications
The drug has no contraindications apart from hypersensitivity reactions.[2]
Side effects
In studies, the most serious side effects of the combination olaratumab/doxorubicin were
Interactions
No
Pharmacology
Mechanism of action
Olaratumab inhibits growth of tumour cells by blocking subunit alpha of the platelet-derived growth factor receptor, a type of tyrosine kinase.[2]
Pharmacokinetics
After
History
Olaratumab was originally developed by
In February 2015, the European Medicines Agency assigned olaratumab orphan drug status for the treatment of soft-tissue sarcoma.[12] The European Commission granted a conditional marketing authorisation, based on the mentioned Phase II study, valid throughout the European Union on 9 November 2016.[13]
Previously considered a promising drug, the FDA granted olaratumab
A Phase III trial completed in 2019, and unfortunately showed no benefit from the addition of olaratumab to doxorubicin.[14][15] As noted above, these results led to withdrawal of approval in the United States and Europe.
References
- ^ "Statement on a Nonproprietary name adopted by the USAN Council: Olaratumab" (PDF). Archived from the original (PDF) on 15 August 2016. Retrieved 18 March 2010.
- ^ a b c d e f g "EPAR – Product information for Lartruvo" (PDF). European Medicines Agency. 23 November 2016.
- ^ US FDA. 19 October 2016.
- PMID 27291997.
- ^ "FDA, EMA Recommend Against Starting Olaratumab for Soft Tissue Sarcoma". OncLive. 25 January 2019.
- ^ "EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo" (PDF).
- ^ "Drug Safety Mail 2019-25 by Arzneimittelkommission der Deutschen Ärzteschaft (in German)". 7 May 2019.
- ^ "FDA Purple Book Data". U.S. Food and Drug Administration. August 2020. Retrieved 23 September 2020.
- ^ "Imclone legacy drug gains green light for Lilly in soft tissue sarcoma". BioWorld. Archived from the original on 1 January 2017. Retrieved 31 December 2016.
- PMID 24816152.
- ^ Clinical trial number NCT01185964 for "A Study of IMC-3G3 in Soft Tissue Sarcoma" at ClinicalTrials.gov
- ^ "Orphan Designation for olaratumab". European Medicines Agency. 9 April 2015.
- ^ "EPAR summary for the public for Lartruvo" (PDF). European Medicines Agency. 23 November 2016.
- ^ S2CID 3604814.
- ^ Clinical trial number NCT02451943 for "A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma (ANNOUNCE)" at ClinicalTrials.gov
External links
- "Olaratumab". Drug Information Portal. U.S. National Library of Medicine.